G7 AC E TABULAR SYSTEM Surgical Technique

One Surgeon. One Patient.

Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it’s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled.

G7 Acetabular System

Table of Contents Quick Reference Guides............................................................................................................................................................................................... 2 Device Description........................................................................................................................................................................................................ 6 Preoperative Templating............................................................................................................................................................................................. 7 Patient Positioning........................................................................................................................................................................................................ 8 Acetabular Exposure..................................................................................................................................................................................................... 8 Acetabular Reaming...................................................................................................................................................................................................... 9 Optional Shell Trialing and Alignment.................................................................................................................................................................10 Positioning Guides Liner Trialing with Provisional Shell.......................................................................................................................................................................15 Trial Reduction and Range of Motion...................................................................................................................................................................16 Acetabular Shell Insertion.........................................................................................................................................................................................17 Supplemental Screw Fixation..................................................................................................................................................................................21 Optional Liner Trialing with Final Implant..........................................................................................................................................................23 Optional Apical Plug...................................................................................................................................................................................................24 Polyethylene Liner Insertion....................................................................................................................................................................................25 Ceramic Liner Insertion..............................................................................................................................................................................................26 Modular Head Selection and Impaction.............................................................................................................................................................28 Final Reduction.............................................................................................................................................................................................................28 Polyethylene Liner Removal.....................................................................................................................................................................................28 Ceramic Liner Removal..............................................................................................................................................................................................31 Primary Shell Removal...............................................................................................................................................................................................31 Straight Inserter Handle Assembly/Disassembly.............................................................................................................................................32 Curved Inserter Handle Assembly/Disassembly...............................................................................................................................................33 Implants...........................................................................................................................................................................................................................34 Instruments....................................................................................................................................................................................................................48 Indications......................................................................................................................................................................................................................68 Contraindications.........................................................................................................................................................................................................68

Biomet as the manufacturer of the G7 System does not practice medicine. This surgical techniuqe was developed in conjunction with healthcare professionals.

G7 Acetabular System Quick Reference Surgical Technique

Step 2: Reaming

Step 3: Instrument Selection

Step 4: Shell Trialing (optional)

Step 5: Shell Insertion

Step 6: Supplemental Screw Insertion (optional)

Step 7: Liner Trialing

Step 8: Liner Insertion

Step 1: Preoperative Planning OrthoSize.com

Step 9: Final Reduction

Note: There may be slight variations in colors between components.

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Quick Reference Implant Guide

SHELLS

OsseoTi Limited and Multi Hole

PPS and BoneMaster Limited Hole

Finned PPS and BoneMaster Limited Hole

LINERS

10 Degree

Neutral

BIOLOX® delta Ceramic

(E1 & ArComXL)

(E1 & ArComXL)

High Wall

Freedom Constrained

(E1 & ArComXL)

(E1 only)

FEMORAL HEADS

CoCr Modular

Freedom CoCr

BIOLOX® delta

BIOLOX® delta Option

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G7 Acetabular System Quick Reference Polyethylene Guides

≈ Minimum Poly Liner Thickness at 45° (mm)

Shell Size 42 - A 44 - A

≈ Minimum Poly Liner Thickness at Apex (mm)

Head Size 28

32

36

40

Shell Size

44

42 - A

4.3

44 - A

28

32

36

40

44

4.7

46 - B

6.3

4.3

46 - B

6.7

4.7

48 - C

7.3

5.3

48 - C

7.7

5.7

50 - D

8.3

6.3

4.3

50 - D

8.7

6.7

4.7

52 - E

9.3

7.3

5.3

52 - E

9.7

7.7

5.7

10.3

8.3

6.3

4.3

10.7

8.7

6.7

4.7

11.3

9.3

7.3

5.3

11.7

9.7

7.7

5.7

11.3

9.3

7.3

11.7

9.7

7.7

5.7

11.7

9.7

7.7

14.7

12.7

10.7

54 - F 56 - F 58 - G 60 - G 62 - H 64 - H

54 - F 56 - F 58 - G 60 - G 62 - H

5.3

64 - H

66 - I 68 - I 70 - I*

66 - I 11.3

9.3

68 - I

7.3

70 - I*

72 - I*

72 - I*

74 - J*

74 - J*

76 - J* 78 - J*

14.3

12.3

76 - J*

10.3

78 - J*

80 - J*

80 - J*

* Available in OsseoTi Multi hole configuration only

45° Apex

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Head Size

Quick Reference Polyethylene Guides

Polyethylene Articulation Sizing

Shell 42 - A 44 - A 46 - B

10 Degree Face Changing Leg Length Chart

Head Size 28

32

36

40

44

42 mm

A - 28 B - 28

Cup Size

44 mm 46 mm

B - 32

Leg Length

Lateralization

(mm)

(mm)

3.2

2.4

2.1

B

3.6

2.7

2.3

Line Size

Offset (mm)

A

48 - C

C - 28

C - 32

48 mm

C

3.7

2.8

2.4

50 - D

D - 28

D - 32

D - 36

50 mm

D

3.9

3

2.6

52 - E

E - 28

E - 32

E - 36

52 mm

E

4.1

3.1

2.7

F

4.3

3.2

2.8

G

4.4

3.4

2.9

H

4.8

3.6

3.1

I

5.1

3.9

3.3

J*

5.7

4.3

3.7

54 - F 56 - F 58 - G 60 - G 62 - H 64 - H

F - 28

F - 32

F - 36

F - 40

G - 28

G - 32

G - 36

G - 40

54 mm 56 mm 58 mm 60 mm 62 mm

H - 32

H - 36

H - 40

H - 44

66 mm

66 - I 68 - I 70 - I*

68 mm I - 36

I - 40

I - 44

72 mm 76 mm

74 - J*

78 - J*

70 mm 74 mm

72 - I*

76 - J*

64 mm

78 mm J - 36

J - 40

J - 44

80 mm

80 - J* *Available in OsseoTi Multi hole configuration only

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G7 Acetabular System Surgical Technique

Figure 1

G7 Acetabular System Color & Letter Coding Key



Color and Liner Size

Shell Size(s)

A

42,44 mm

B

46 mm

C

48 mm

D

50 mm

E

52 mm

F

54,56 mm

G

58,60 mm

H

62,64 mm

I

66, 68, 70*, 72* mm

J*

74, 76, 78, 80 mm

*Only available in multi hole shell configurations Figure 2

Device Description The hemispherical design of the G7 acetabular shell provides fixation and stability with proven PPS Porous Plasma Spray Coating or OsseoTi Porous Structure. Multiple bearing options are also available, including E1 Antioxidant Infused Technology, ArComXL Polyethylene and BIOLOX® delta ceramic liners. The G7 Acetabular System utilizes a unique color coding system designed to offer an efficient operating experience. The provisional shells, provisional liners, labels and face plate impactors match the color anodized on the rim and letter designation of the acetabular shell implant (Figure 1).

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The G7 Acetabular System color and letter coding key is listed in Figure 2. Note: Implant identification should be made using letter and size information. Color coding should be used only as a secondary reference. There may be slight variations in colors between components.

OrthoSize.com

Preoperative Templating Accurate preoperative planning and acetabular templating help determine the size, desired location and position of the acetabular shell and are an essential part of the surgical process. Templating is best performed with an A/P pelvis radiograph with the limb internally rotated approximately 15 degrees. This allows more accurate determination of femoral offset, radiographic leg length inequality, and referencing of contralateral hip, if required. When examining the A/P radiograph, the shell should be positioned against, but not medial to, the radiographic teardrop at 40 degrees of inclination. Acetabular shell size is best determined on a cross-table lateral radiograph. If the patient’s anatomy is obscured, it may be helpful to check the acetabular component size on the contralateral hip radiograph, as well.

Make note of the shell size that fills the acetabular space appropriately and fits the anterior to posterior diameter of the native acetabulum, keeping in mind that final decision on shell size should be made during surgery when adequate visualization of the acetabulum is achieved. Note: Use of an X-ray magnification marker is needed to template with OrthoSize Digital Templating Software. The magnification marker can be located against the joint (ball/coin) or on the table (coin/ruler), but must be visible within the X-ray.

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G7 Acetabular System

Figure 3

8

Patient Positioning

Acetabular Exposure

The G7 Acetabular System is designed to be used with all surgical approaches (Figure 3).

Prior to reaming, acetabular exposure should be adequate and the anterior, posterior and superior walls should be directly visible. The medial acetabular wall, which dictates the depth of the reaming, should be uncovered of floor osteophytes or pulvinar pad. Specialized acetabular retractors are available to help facilitate exposure for whichever approach is chosen.

Figure 4

Acetabular Reaming Determine a starting reamer size from the preoperative template and from the measured diameter of the resected femoral head. This is typically 6–8 mm smaller than the femoral head diameter. Reamer handles are provided as straight or curved (offset). Use is dictated by surgeon preference, surgical exposure, and patient body composition. During the reaming process, frequently determine the amount of anterior and posterior acetabular bone remaining to avoid reaming away the wall and compromising fixation. Beginning with a small reamer, apply constant pressure first toward the medial wall, appropriately medializing the acetabulum for optimal hip biomechanics and the normal center of hip rotation. Gradually progress to larger reamers, while maintaining concentricity within the acetabular cavity until bleeding subchondral bone is exposed (Figure 4).

The preferred acetabular orientation is 40 degrees inclination and 20 degrees of anteversion, but final acetabular position depends on patient anatomy and may vary slightly with approach. Final orientation of the acetabular implant is also dictated by the amount of version of the femoral implant (i.e., greater anteversion of the acetabular component may be required in the case of a retroverted stem). Under-reaming of the acetabulum is dependent on bone quality and should be determined by the surgeon intraoperatively as soft bone will more readily accommodate a larger pressfit than harder, sclerotic bone. The following reaming recommendation may be used as an initial guideline:

Acetabular Shell

Recommended Under ream*

G7 PPS and OsseoTi Hemispherical Shell

1 mm under final implant size

G7 Finned Hemispherical Shell

Line to line

* This is a general recommendation only, appropriate reaming is ­ dependent on bone quality and should be determined by the surgeon intraoperatively.

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G7 Acetabular System 180°

47 mm

180°

Figure 5 47 mm

180°

Figure 6

48 mm

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Acetabular Reaming (cont.)

Optional Shell Trialing and Alignment

Once reaming is complete, use the provisional shells to confirm the position and accuracy of the reaming. Final shaping must be achieved using the hemispherical grater reamer to ensure a congruent fit between the shell and the acetabulum.

Once the desired ream has been achieved, select a provisional shell that is 1 mm smaller than the final implant. The provisional shell is marked with its true size and indicates the corresponding liner size both alphabetically and by color (Figure 6).

Note: All G7 acetabular shells are measured over porous coating or structure. All acetabular shells, provisional shells and Biomet acetabular reamers are marked true to size. All components are a full hemisphere and measure 180 degrees (Figure 5).

The shell gauge handle may be threaded to the acetabular shell provisional and used to gauge the size of the reamed acetabulum (Figure 6). Note: Do not impact on the shell gauge handle.

Figure 7

Figure 8

Figure 9

Optional Shell Trialing and Alignment (cont.) Alternatively, utilize either the straight monoblock, curved or straight modular inserter handle. Place the provisional shell into the acetabulum at approximately 40 degrees of inclination and 20 degrees of anteversion.

When using the curved or straight modular handle, place the appropriate threaded shaft into the handle through the hole in the strike plate of the straight modular handle (Figures 7 and 8), or the hole at the distal tip of the curved inserter handle (Figure 9). If using the G7 Straight Monoblock Inserter Handle, assemble to the mating component by rotating clockwise and disassemble by rotating counter-clockwise. Ensure the G7 Monoblock Inserter Handle is fully threaded to the mating component prior to impaction. Note: Levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads.

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G7 Acetabular System

Figure 10

Figure 11

Figure 12

Optional Shell Trialing and Alignment (cont.) Insert the ball hex driver into the hole in the strike plate of the straight handle or the hole at the distal tip of the curved handle and turn to advance the threaded shaft until the threads are exposed (Figures 10 and 11). Line up the square tip of the insertion handle with the square at the apex of the shell trial. Turn the ball hex driver in a clockwise direction to advance the thread into the shell (Figures 10–12). Remove the ball hex driver from the handle. Ensure that the shell is securely fastened to the handle by lightly pulling on the provisional shell.

Approximate version can be obtained by using the transverse acetabular ligament or by referencing the opening of the acetabular component 90 degrees off of the sciatic notch. Alternatively, a positioning guide may be used. If using the G7 Straight Monoblock Inserter Handle, assemble to the mating component by rotating clockwise and disassemble by rotating counter-clockwise. Ensure the G7 Monoblock Inserter Handle is fully threaded to the mating component prior to impaction. Note: Levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads.

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Figure 13

Figure 14

Optional Shell Trialing and Alignment (cont.) Positioning Guides

Lateral Guide

The Lateral and Anterior Supine G7 positioning guides are designed to aid in proper insertion of the acetabular component.

When positioning the acetabular shell, the lateral guide arms should be parallel to the table, aimed toward the patient’s ipsilateral shoulder (Figure 13).

Assemble the positioning guide on the back table before securing to the insertion handle. Connect the body of the positioning guide to the insertion handle by sliding the guide into the opening between the handle grip and shaft on the inserter handle. Slide the positioning guide into the flat opening on the guide body. When the guide is in place, tighten the positioning guide rod to secure the guide to the handle (Figure 14).

For the right hip, use the reference arm of the “V” shaped guide labeled “RIGHT.” For the left hip, use the reference arm of the “V” shaped guide labeled “LEFT” (Figure 14).

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G7 Acetabular System

Figure 15

Optional Shell Trialing and Alignment (cont.) Supine Guide When positioning the acetabular shell, the anterior supine positioning guide arms should be parallel to the table, aligned with the patient’s spinal column (Figure 15). For the right hip, use the reference arm of the “V” shaped guide labeled “RIGHT.” For the left hip, use the reference arm of the “V” shaped guide labeled “LEFT” (Figure 15).

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Note: The primary reference for acetabular shell position should be based on the patient’s anatomy. These instruments rely significantly on patient position and are designed to be used only as a secondary verification. If at any time there is concern about acetabular position, the orientation may be verified with intraoperative fluoroscopy or with intraoperative radiographs. A true A/P pelvis without rotation is best indicated when the tip of the coccyx lines up with the pubic symphysis and is within 1–2 cm of the symphysis.

Figure 16

Optional Shell Trialing and Alignment (cont.) Optional Shell Trialing Lightly impact the provisional shell and confirm complete seating through the cutouts on the provisional shell (Figure 16). Remove any soft tissue or osteophytes from the acetabular rim that overhang the edge of the provisional component to obtain proper seating. If the provisional shell is unstable, or if there are gaps between the provisional shell and the acetabulum, it may be necessary to increase the diameter of the final reamer. However, in some instances it may not be possible to increase the reamed diameter. If this is the case, then supplementary screw fixation may be necessary. Disconnect the inserter handle from the provisional shell.

Figure 17

Liner Trialing with Provisional Shell Following seating of the provisional shell, select the appropriate provisional liner size, as indicated alphabetically and by color, in the desired liner configuration. Insert the provisional liner into the shell by hand. Utilize a 3.5 mm hex screwdriver to tighten the screw in the dome of the provisional liner into the apical hole of the provisional shell (Figure 17). Note: Do not overtighten the provisional liner.

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G7 Acetabular System

Figure 18

Figure 19

Trial Reduction and Range of Motion Select the appropriate provisional head, head diameter and neck length to create equal leg length and needed lateralization as determined by the surgeon. These determinations can be made during preoperative templating, but final adjustments are made intraoperatively. Insert the provisional head onto the implanted stem or broach and reduce the hip (Figures 18 and 19).

16

Ensure the provisional head is seated fully on the trunnion. If using the G7 self retaining provisional head in combination with a Biomet Type 1 reduced taper, a click is felt and/or heard when the provisional head is fully seated. Check for joint stability and range of motion, making any necessary adjustments to restore joint mechanics. Make certain that prominent impinging bone and/or osteophytes are removed from the periphery of the acetabulum to maximize range of motion and stability. Make note of all provisional components used and then remove all provisionals.

Figure 20

Figure 21

Figure 22

Acetabular Shell Insertion Similar to provisional shell insertion, the same curved or straight handle may be used for the final implant shell insertion (Figure 20). Note: Limited hole shells are packaged with the screw holes pre-plugged. Should screw fixation be necessary, the screw hole covers should be removed using a 3.5 mm hex driver prior to shell insertion.

When using the curved or straight handle, place the appropriate threaded shaft (Figures 21 and 22) into the handle through the hole in the strike plate of the straight handle, or the hole at the distal tip of the curved handle inserter. If using the G7 Straight Monoblock Inserter Handle, assemble to the mating component by rotating clockwise and disassemble by rotating counter-clockwise. Ensure the G7 Monoblock Inserter Handle is fully threaded to the mating component prior to impaction.

17

G7 Acetabular System

Figure 23

Figure 24

Acetabular Shell Insertion (cont.) Insert the ball hex driver into the hole in the strike plate of the straight handle or the hole at the distal tip of the curved handle and turn to advance the threaded shaft until the threads are exposed. Line up the square tip of the insertion handle with the square indentation on the inside of the G7 shell (Figure 23). Turn the ball hex driver in a clockwise direction to advance the thread into the shell (Figure 24). Note: If the threads begin to loosen when impacting the modular inserter handle, utilize the ball hex driver to retighten and continue impaction.

18

Remove the ball hex driver from the handle. Note: When the curved handle is used, the curve of the insertion handle should line up with the screw holes on the shell. Ensure the shell is securely fastened to the handle by lightly pulling on the shell.

Figure 25

Figure 26

Acetabular Shell Insertion (cont.) Alternatively, each inserter handle may also be utilized to insert the shell with a face plate impactor. Select the appropriately sized impactor plate that matches alphabetically and by color to the implant. Thread the impactor plate onto the insertion handle with the word “insert” facing the user (Figure 25).

The face plate impactor will align with any of the anti-rotation tabs on the face of the shell for impaction. These plates may be used with or without the optional quick connect bolt, which threads onto the face plate impactor (Figure 26). This bolt then snaps into the apical hole of the implant to retain the shell on the face impactor. Once inserted, the face plate is disengaged from the shell by lightly pulling backwards.

19

G7 Acetabular System

Figure 27

Acetabular Shell Insertion (cont.) Optional use of Positioning Guide The Lateral and Anterior Supine G7 positioning guides are designed to aid in proper insertion of the acetabular component. Utilizing the positioning guide as a reference, determine the correct position and alignment of the acetabular shell. See positioning guide section (Pages 13 and 14). In addition, approximate version can be obtained by using the transverse ligament or by referencing the opening of the acetabular component 90 degrees off of the sciatic notch. Position of the acetabular shell is crucial for optimizing wear, reducing impingement, reducing dislocation and reducing potential adverse outcomes. Use a mallet to impact the handle on the strike plate, driving the shell into the acetabulum. While impacting, note the position of the screw holes to obtain the optimal position for screw placement, typically in the posterior/ superior quadrant of the acetabulum (Figure 27). There are 2 indents on the shell rim, to provide a secondary reference in identifying screw hole locations after the implant is inserted.

Gently toggle the insertion handle to make certain the shell is stable. Once the implant is fully seated, reinsert the ball hex driver and turn in a counter-clockwise direction to release the threads from the shell. If using an impactor plate, pull back gently from the shell to disengage the plate. Check through the apical hole to determine whether the shell is in full contact with the floor of the acetabulum. If not, the impactor handle may be re-attached to the shell for further impaction, until the shell is fully seated. Failure to fully seat the shell into the acetabulum may compromise the quality of fixation. The force required to fully seat the implant depends on multiple factors including quality of bone, diameter of acetabulum and amount of underream. Ensure the G7 Straight Monoblock Inserter Handle is fully threaded to the mating component prior to impaction. Note: Levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads. Note: Consideration should be given to the location of screw holes prior to impaction if screws will be used.

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Limited hole configuration

Figure 28

Multi hole configuration

Figure 29

Supplemental Screw Fixation For primary cases where good bone stock is present and the shell is firmly seated within the acetabulum, the use of fixation screws is generally unnecessary. However, in cases where press-fit stability is in question, or where the bone quality is not optimal, supplementary screw fixation is advised. Screw placement must be chosen carefully to avoid injury to neurovascular structures. Optimal position for screw placement is typically in the posterior/superior quadrant of the acetabulum (Figure 28). Care should also be exercised when supplementary screw fixation is required to avoid damaging or scratching the internal surfaces of the acetabular components.

Use of the gold drill guide is required for accurate screw placement. Consideration should be given to placement of a screw near the dome of the implant first to prevent possible shifting of the implant caused when placing peripheral screws. Note: Placement of screws outside of the “safe zone” may inadvertently injure neurovascular structures and should be utilized at the discretion of the operating surgeon. When using G7 Limited Hole shells, screws should never be placed in the anterior/medial area of the acetabulum. When using the G7 OsseoTi Multi Hole shell, extreme caution should be used if screw placement is required in the anterior/medial area of the acetabulum.

21

G7 Acetabular System

Figure 30

Figure 31

Figure 32

Supplemental Screw Fixation (cont.) Use the gold drill guide to drill a pilot hole in the desired screw hole (Figure 29). Make certain the drill guide is fully seated and locked into position within the screw hole BEFORE the drill bit begins to engage bone (Figure 30). This will ensure the appropriate screw direction can be achieved. The G7 screw holes allow approximately 15 degrees of variability. Screws oriented outside this range may result in incomplete seating of the screws and prominent screw heads within the shell, which could impede insertion of the liner. When drilling into the posterior/superior quadrant, place a finger posteriorly into the sciatic notch to ensure the screw cannot penetrate too deeply. Note: Levering on the drill bit during drilling may cause damage to the drill bit. Note: Use only gold colored screws and the gold colored drill guide with G7 implants. Note: Check that all screw heads are seated below the inner surface of the shell to ensure proper liner seating.

22

The drill bits are available in variable lengths. However, 30 or 40 mm drill bits are most commonly utilized. The drill bit chosen should be dictated by surgeon choice and the projected length of the screws. To ensure proper seating of the G7 acetabular screw after drilling pilot holes, it is important to remove all bone debris from the screw hole prior to placing the screw. After measuring the depth of the hole with the depth gauge (Figure 31), select the 6.5 mm gold colored screw with the corresponding length and insert it into the hole with the 3.5 mm hex screwdriver and screw forceps (Figure 32). Place additional screws as needed. Screws should not be placed in the apical hole of the shell.

Figure 33

Figure 34

Optional Liner Trialing with Final Implant Clean and dry the shell and clear all soft tissue from around its perimeter. If another trial reduction is desired, utilize the provisional liner colored to match the rim of the shell and previously selected during the earlier trial reduction with the matching letter designation. Insert the provisional liner into the shell by hand, utilizing a 3.5 mm hex screwdriver, tighten the screw in the dome of the provisional liner into the apical hole of the final implant (Figure 33). Note: Do not overtighten the provisional liner. Note: For ease of insertion, ensure the screw in the dome of the liner provisional is aligned with the apical hole of the final implant. Insert a provisional head onto the femoral stem and perform the trial reduction (Figure 34). When selection of the appropriate liner is complete, remove all provisional components.

When using a High Wall or 10 Degree Face Changing liner, note the position of the liner to maintain orientation during final seating or adjust rotation as necessary in order to minimize impingement and optimize stability.

Freedom Constrained Liner Trialing Determine the desired neck length and head size and select the appropriate trial head. Insert the provisional head onto the implanted stem or broach. Ensure the provisional head is seated fully on the trunnion and reduce the hip. Check for joint stability and range of motion, making any necessary adjustments to restore joint mechanics. Make certain that prominent impinging bone and/or ostephytes are removed from the periphery of the acetabulum to maximize range of motion and stability. Make note of all provisional components used and then remove all provisionals. Note: Only Freedom provisional heads are compatible for trialing with Freedom implant liners.

Note: G7 provisional heads are designed with a retaining feature. A click is felt and/or heard when the provisional head is fully seated.

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G7 Acetabular System

Figure 35

Optional Apical Plug If desired, the apical hole in the acetabular shell can be covered with the plug packaged with the implant. Place the apical hole plug on the 3.5 mm hex screwdriver. Align the plug with the apical hole and twist the screwdriver clockwise to tighten the plug (Figure 35). Placing a drop of blood on the end of the screwdriver prior to attaching it to the apical hole plug may aid in retention of the plug on the screwdriver tip. Note: Only G7 Limited Hole Shells are packaged with an apical plug.

24

˚

90

Freedom Plug Removal Cross Section Figure 36

Figure 38

Incorrect Polyethylene Seating

Correct Polyethylene Seating

Figure 39

Correct Freedom Constrained Liner Seating

Figure 37

Polyethylene Liner Insertion The definitive polyethylene liner may now be introduced. The color on the liner label should match the color anodized on the rim of the acetabular shell. Ensure the interior of the shell is dry and free of debris and overhanging soft tissue is removed. Manually place the liner into the shell, ensuring the scallops are correctly aligned with the recessed areas on the shell. Apply gentle manual pressure to the dome region to provisionally secure the liner in place by lightly engaging the scallops. Utilizing the appropriately sized G7 ball impactor, place the tip of the impactor on the dome of the liner and strike the impactor with the mallet to ensure proper seating of the liner (Figure 36). Check to ensure the liner is fully seated by running your finger around the face of the shell. When properly seated, the polyethylene liner and tabs will sit flush with, or slightly below, the face of the shell (Figure 37). When inserting a 10 degree liner, the higher side of the liner should be placed superiorly. Ensure the insertion handle is perpendicular to the rim of the shell (Figure 38). Continue to impact with the handle perpendicular to the rim of the shell until the liner is fully seated. Do not impact

Note: If incomplete seating occurs, continue to impact the liner in the center, do not impact the sides of the liner. Note: The ball impactor is slightly undersized to prevent excessive forces at the rim that may cause polyethylene deformation and prevent full seating.

Freedom Constrained Liner Insertion Remove the black plug covering the mouth of the liner with the Freedom plug removal tool (Figure 39); discard this plug. Place the liner into the acetabular shell. When satisfied with placement, using the appropriately sized G7 Freedom ball impactor, place the tip of the impactor on the dome of the liner and strike the impactor with the mallet to ensure proper seating of the liner. Pull on the liner by hand after insertion to ensure proper seating has been achieved. Note: The diameter of the G7 36 mm size D Freedom liner ring is slightly larger than the G7 50 mm D shell. Care should be taken when using this construct.

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G7 Acetabular System G7 Ceramic Articulation Shell 46 B

Head Size 28

32

36

40

B 28

48 C

C 32

50 D

D 32

52 E

E 32

E 36

F 32

F 36

G 32

G 36

G 40

H 32

H 36

H 40

I 32

I 36

I 40

54 F 56 F 58 G 60 G 62 H 64 H 66 I 68 I *70 I

Figure 41

*72 I * Only available in OsseoTi Multi hole configuration

Figure 40

Ceramic Liner Insertion The definitive ceramic liner may now be introduced (Figure 40). Ensure the interior of the shell and all tapers are dry and free of debris. Utilizing the straight insertion handle with a suction cup attached or the bent suction cup handle, being careful not to misalign the liner, insert the ceramic liner into the shell by first positioning the suction cup on the liner at the 11 o’clock position (Figure 41). This angular placement helps to ensure straight seating of the liner.

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Once attached to the suction cup, align the ceramic liner with the most anterior point of the acetabular shell, leading with the attachment point of the suction cup (Figure 41). Gently seat the liner into the taper. The button on the back of the liner will help aid alignment. Once inserted, push on the liner to seat fully. Rotate the suction cup clockwise to disengage from the liner. Prior to impaction, ensure the edge of the liner is properly aligned in relation to the face of the rim. Utilizing the appropriately sized liner impactor, place the tip of the impactor on the dome of the liner and strike the impactor with the mallet to ensure proper seating of the liner (Figure 42). Check to ensure the liner is fully seated by running your finger around the face of the shell (Figure 43). When properly seated, the liner will sit flush with, or slightly above, the face of the shell (Figure 44).

Figure 42

Figure 43

Correct Ceramic Liner Seating

Figure 44

Figure 45 Figure 46

Ceramic Liner Insertion (cont.) Hard Bearing Inserter Tool If using the straight hard bearing inserter tool, select the face plate corresponding to the letter and color of the shell size implanted. Turn the insertion plate upside down so that the word “extract” is facing you and attach it to the inserter tool. Insert the shaft into the inserter tool and thread through the face plate. Depress the shaft to fully expose its threads for attachment of the suction cup to the end of the shaft (Figure 45).

Utilizing the appropriately sized liner impactor, place the tip of the impactor on the dome of the liner and strike the impactor with the mallet to ensure proper seating of the liner (Figure 42). Check to ensure the liner is fully seated by running your finger around the face of the shell (Figure 43). When properly seated, the liner will sit flush with, or slightly above, the face of the shell (Figure 44).

Depress the shaft to fully extend the suction cup and attach to the apex of the ceramic liner. Release the shaft to draw the liner to the face plate. Prior to insertion, ensure the interior of the shell and all tapers are dry and free of debris. Align the tabs of the face plate with the three recessed areas on the face of the shell and firmly insert into the shell (Figure 46). Firmly depress the shaft to engage the tapers of the liner and shell.

IMPORTANT: Care should be taken not to scratch the taper surface of either the bearing or the shell. If the liner must be removed for any reason, a new shell must be inserted before inserting another ceramic liner.

Note: Do not impact the hard bearing inserter tool.

Note: To release a ceramic liner which is malpositioned, the G7 Tamp instrument is available. Line the tab up to one of the three recessed areas on the face of the shell. Hit the impactor area with the mallet several times to cause vibration and loosen the liner. Use the suction cup to grasp the liner and remove from the shell.

To disengage the instrument from the liner, twist the shaft clockwise. In liners with inner diameter sizes 36 mm and larger, you may pull up on the shaft to disengage the suction cup from the liner.

27

G7 Acetabular System Freedom Etching

Figure 47

Figure 48

Modular Head Selection and Impaction With the definitive acetabular bearing in place, and upon completion of femoral implantation and trial reduction, the corresponding modular head can now be selected. After fully seating the femoral component, position the modular head onto a dry and clean trunnion. Fully seat the modular head by means of firm axial impaction utilizing the femoral head pusher and mallet. Note: If using a modular ceramic head with taper sleeve insert, it is important that the taper sleeve is new as a used taper can reduce fatigue strength of ceramic components. Note: When utilizing the Freedom liner, position the Freedom head on the stem so that the marking on the head is located in the most superior position prior to impaction.

Final Reduction Once all final implants have been placed, perform the final reduction of the hip. Check for joint stability and range of motion, making any necessary adjustments to restore joint mechanics (Figure 47).

28

Note: When reducing a hip using the Freedom Constrained liner and head, ensure that the marking on the head is still in the superior position on the stem (Figure 48). Reduce the joint by aligning the flat aspect of the head with the liner’s mouth. Full reduction may produce an audible “snap.” Place the joint through a full range of motion to ensure stability, checking that there is no early impingement.

Figure 49

Polyethylene Liner Removal Should it be necessary to remove the liner from the shell, the polyethylene liner removal tool can be used to disassociate the liner. To remove the liner, insert the pointed tip of the liner removal tool between the liner and the shell with the tip positioned between the liner scallops. Start insertion with the grip angled toward the inner diameter of the shell. As the wedge is driven between the shell and the liner, gradually rotate the grip until vertical. Impact the polyethylene liner removal tool until the shoulder fully rests on the face of the shell (Figure 49). Apply a lever force to the liner by pressing against the shaft of the liner removal tool. It may be necessary to do this in several locations around the face of the shell to disengage the locking mechanism. The polyethylene liner will lever out of the shell once the locking mechanism has been disrupted. Note: Avoid driving the metal tip along the tapered region of the shell to prevent damage to the taper during liner extraction. Note: The polyethylene liner removal tool should only be used on a well fixed cup or a cup with acetabular screws.

10 Degree Liner

High Wall Liner

Figure 50

Figure 51

Polyethylene Liner Removal (cont.) Neutral Liner Removal Using Drill Instruments If using the Poly Liner Removal Drill Bit and Screw, first select the face plate corresponding to the letter and color of the shell size implanted. Turn the face plate upside down so that the word “extract” is facing you and attach it to an insertion handle. Align the tabs of the face plate to the recessed areas on the face of the shell. Insert the G7 Poly Liner Removal Drill Bit into either drill hole of the face plate (Figure 50). Drill a pilot hole for the poly removal screw and advance until the shoulder of the drill bit touches the face plate.

Figure 52

Figure 52a

10 Degree and High Wall Liner Removal with Drill Instruments Position the G7 Poly Liner Removal Drill Bit at the face of the polyethylene liner. Angle the drill bit at approximately 15 degrees from the axis of the shell and drill a pilot hole for the poly removal screw (Figure 52a). Should the drill cut through into the inner diameter of the polyethylene, drill a new hole in an alternate location around the rim, slightly decreasing the entrance angle relative to the axis of the shell.

Remove the face plate and handle. Using the ratcheting screwdriver handle, insert the Poly Liner Removal Screw into the pilot hole, advancing it all the way to the shell dome to remove the liner (Figures 51 and 52).

Drill the pilot hole until the shoulder of the drill bit touches the face of the liner or the drill tip touches the dome of the shell. Using the ratcheting screwdriver handle, insert the Poly Liner Removal Screw into the polyethylene and advance it all the way to the shell dome to remove the liner.

Note: The Poly Liner Removal Drill Bit and Poly Liner Removal Screw are delivered sterile for single use.

Note: The Poly Liner Removal Drill Bit and Poly Liner Removal Screw are delivered sterile for single use.

Note: If the screw enters one of the shell screw holes, remove the screw and repeat in an alternate location with a new drill bit and screw.

Note: If the screw enters one of the shell screw holes, remove the screw and repeat in an alternate location with a new drill bit and screw.

29

G7 Acetabular System

15 Degrees

Figure 53

Figure 54

Figure 55

Polyethylene Liner Removal (cont.) Freedom Liner Removal Place the Poly Liner Removal Drill Bit at the interface of the liner and the constraining ring. Angle the drill bit at approximately 15° from the axis of the shell and drill a pilot hole for the poly removal screw (Figure 53).

Drill the pilot hole until the shoulder of the drill bit touches the face of the liner. Insert the Poly Liner Removal Screw into the poly and advance it all the way to the shell dome to remove the liner (Figure 54 and 55).

The drill should only enter the polyethylene, but remain close to the constraining ring.

Note: For sizes I & J, the poly removal drill bit may be inserted through the exposed polyethylene scallops or the polyethylene liner removal tool may be used in the same manner as with non-constraining liners.

Should the drill cut through into the inner diameter of the polyethylene, drill a new hole in an alternate location around the rim, slightly decreasing the entrance angle relative to the axis of the shell.

30

Figure 58

Figure 56

Figure 59 Figure 57

Ceramic Liner Removal

Primary Shell Removal

Should it be necessary to remove the ceramic liner, the insertion/extractor plates can be used. Select the appropriate face plate that matches the letter and color of the implant. Turn the insertion plate upside down so that the word “EXTRACT” is facing you and attach it to the straight impactor handle. Align the tabs of the face plate with the three recessed areas on the face of the shell (Figure 56). Hit the impactor handle with the mallet several times to cause vibration and loosen the liner. Use the suction cup to grasp the liner and remove from the shell (Figure 57).

To remove the acetabular shell, thread the extractor tool to a standard slap hammer and thread into the apical hole of the shell. Utilize the slap hammer to pull the shell directly out of the acetabulum, conserving as much bone as possible (Figure 58). Once the component is removed, careful evaluation of the acetabulum is suggested, with close attention to the integrity of the anterior/posterior columns and the medial wall. Any osteolytic cysts should be curetted and irrigated.

Note: To release a ceramic liner which is malpositioned, the G7 Tamp instrument is available. Line the tab up to one of the three recessed areas on the face of the shell. Hit the impactor area with the mallet several times to cause vibration and loosen the liner. Use the suction cup to grasp the liner and remove from the shell.

Note: In the unlikely event that the inserter handle

threads may fracture during impaction and be left in the apical hole of the acetabular shell, utilize the Thread Extractor instrument for removal. The tapered tip of the Thread Extractor may be engaged in the small through hole of the fractured threads, allowing the fractured threads to be removed from the apical hole of the acetabular shell (Figure 59).

31

G7 Acetabular System Inserter Handle Assembly/Disassembly

Figure 60

Figure 61

Figure 62

Figure 63

Straight Inserter Handle Assembly/Disassembly Insertion handles are available in both curved and straight designs for ease of use, to limit modularity and to allow appropriate and thorough cleaning of instrumentation. Step 1: Obtain the straight inserter handle body and threaded shaft (Figure 60). Step 2: Insert the threaded shaft into the hole in the strike plate of the straight inserter handle body (Figure 61).

32

Step 3: Insert the ball hex driver into the hole in the strike plate of the straight inserter handle body. Turn clockwise to advance the threads of the internal shaft through the tip of the impaction handle (Figure 62). Step 4: To disassemble for cleaning, place a 3.5 mm hex screwdriver in the tip of the threaded shaft. Turn the screwdriver clockwise while pushing lightly to disengage the threaded shaft from the handle (Figure 63).

Figure 64

Figure 65

Figure 66

Figure 67

Curved Inserter Handle Assembly/Disassembly Step 1: Obtain the curved inserter handle body and the threaded insert (Figure 64). Step 2: Place the threaded insert into the tip of the handle body (Figure 65).

Step 3: Insert the ball hex driver into the hole in the tip of the curved handle as shown. The handle is designed to allow the user to angle the ball hex driver away from the inserter handle grip. Turn clockwise to advance the threads of the internal shaft through the tip of the impaction handle (Figure 66). Step 4: To disassemble for cleaning, place a 3.5 mm hex screwdriver in the tip of the threaded insert. Turn the screwdriver clockwise while pushing lightly to disengage the insert (Figure 67).

33

G7 Acetabular System Implants Product

Part Number

Diameter

Size/Offset

010000658

42 mm

A

010000659

44 mm

A

010000660

46 mm

B

010000661

48 mm

C

010000662

50 mm

D

010000663

52 mm

E

54 mm

F

56 mm

F

010000666

58 mm

G

010000667

60 mm

G

010000668

62 mm

H

010000669

64 mm

H

010000670

66 mm

I

010000671

68 mm

I

010000698

42 mm

A

010000699

44 mm

A

010000700

46 mm

B

010000701

48 mm

C

010000702

50 mm

D

010000703

52 mm

E

54 mm

F

56 mm

F

010000706

58 mm

G

010000707

60 mm

G

010000708

62 mm

H

010000709

64 mm

H

010000710

66 mm

I

010000711

68 mm

I

010000664 010000665

010000704 010000705

34

Description

PPS Limited Hole Acetabular Shell

BoneMaster Limited Hole Acetabular Shell

Implants Product

Part Number

Diameter

Size/Offset

110017098

42 mm

A

110017099

44 mm

A

46 mm

B

48 mm

C

110017102

50 mm

D

110017103

52 mm

E

110017104

54 mm

F

110017105

56 mm

F

110017106

58 mm

G

60 mm

G

62 mm

H

110017109

64 mm

H

110017110

66 mm

I

110017111

68 mm

I

110017118

42 mm

A

110017119

44 mm

A

46 mm

B

48 mm

C

110017122

50 mm

D

110017123

52 mm

E

110017124

54 mm

F

110017125

56 mm

F

110017126

58 mm

G

60 mm

G

62 mm

H

110017129

64 mm

H

110017130

66 mm

I

110017131

68 mm

I

110017100 110017101

110017107 110017108

110017120 110017121

110017127 110017128

Description

PPS Finned Limited Hole Acetabular Shell 3 Hole*

PPS Finned Limited Hole Acetabular Shell 4 Hole*

BoneMaster Finned Limited Hole Acetabular Shell 3 Hole*

BoneMaster Finned Limited Hole Acetabular Shell 4 Hole*

*3 or 4 hole pattern dependent on shell diameter

35

G7 Acetabular System Implants Product

Part Number

Diameter

Size/Offset

110010239

42 mm

A

110010240

44 mm

A

46 mm

B

48 mm

C

110010243

50 mm

D

110010244

52 mm

E

110010245

54 mm

F

110010246

56 mm

F

110010247

58 mm

G

60 mm

G

62 mm

H

110010250

64 mm

H

110010251

66 mm

I

110010252

68 mm

I

110010259

42 mm

A

110010260

44 mm

A

110010261

46 mm

B

110010262

48 mm

C

110010263

50 mm

D

110010264

52 mm

E

110010265

54 mm

F

110010266

56 mm

F

110010267

58 mm

G

60 mm

G

62 mm

H

110010270

64 mm

H

110010271

66 mm

I

110010272

68 mm

I

110010273

70 mm

I

110010274

72 mm

I

110010275

74 mm

J

110010276

76 mm

J

110010277

78 mm

J

110010278

80 mm

J

110010241 110010242

110010248 110010249

110010268 110010269

*3 or 4 hole pattern dependent on shell diameter

36

Description

OsseoTi Limited Hole Acetabular Shell 3 Hole*

OsseoTi Limited Hole Acetabular Shell 4 Hole*

OsseoTi Multi Hole Acetabular Shell

Implants Product

Part Number

Description

Diameter

Size

010000718

A

010000719

B

010000720

C

010000721

28 mm

D

010000722

E

010000723

F

010000724

G

010000729

B

010000730

C

010000731

D

010000732

32 mm

010000733

E F

010000734

G

010000735

H

010000736

I

Neutral ArComXL Liner

010000739

D

010000740

E

010000741

F

010000742

36 mm

G

010000743

H

010000744

I

010000745

J

010000747

F

010000748

G

010000749

40 mm

H

010000750

I

010000751

J

010000753

H

010000754 010000755

44 mm

I J

37

G7 Acetabular System Implants Product

Part Number

Description

Diameter

010000835

A

010000836

B

010000837

C

010000838

28 mm

D

010000839

E

010000840

F

010000841

G

010000846

B

010000847

C

010000848

D

010000849

32 mm

E

010000850

F

010000851

G

010000852 010000856

H Neutral E1 Liner

D

010000857

E

010000858

F

010000859

36 mm

G

010000860

H

010000861

I

010000862

J

010000864

F

010000865

G

010000866

40 mm

H

010000867

I

010000868

J

010000870

H

010000871 010000872

38

Size

44 mm

I J

Implants Product

Part Number

Description

Diameter

Size

010000796

A

010000797

B

010000798

C

010000799

28 mm

D

010000800

E

010000801

F

010000802

G

010000807

B

010000808

C

010000809

D

010000810

32 mm

E

010000811

F

010000812

G

010000813

H

010000814

I

High Wall ArComXL Liner

010000817

D

010000818

E

010000819

F

010000820

36 mm

G

010000821

H

010000822

I

010000823

J

010000825

F

010000826

G

010000827

40 mm

H

010000828

I

010000829

J

010000831

H

010000832 010000833

44 mm

I J

39

G7 Acetabular System Implants Product

Part Number

Description

Diameter

010000913

A

010000914

B

010000915

C

010000916

28 mm

D

010000917

E

010000918

F

010000919

G

010000924

B

010000925

C

010000926

D

010000927

32 mm

E

010000928

F

010000929

G

010000930 010000934

H High Wall E1 Liner

D

010000935

E

010000936

F

010000937

36 mm

G

010000938

H

010000939

I

010000940

J

010000942

F

010000943

G

010000944

40 mm

H

010000945

I

010000946

J

010000948

H

010000949 010000950

40

Size

44 mm

I J

Implants Product

Part Number

Description

Diameter

Size

010000757

A

010000758

B

010000759

C

010000760

28 mm

D

010000761

E

010000762

F

010000763

G

010000768

B

010000769

C

010000770

D

010000771

32 mm

010000772

E F

010000773

G

010000774

H

010000775

I

10 Degree Face Changing ArComXL Liner

010000778

D

010000779

E

010000780

F

010000781

36 mm

G

010000782

H

010000783

I

010000784

J

010000786

F

010000787

G

010000788

40 mm

H

010000789

I

010000790

J

010000792

H

010000793 010000794

44 mm

I J

41

G7 Acetabular System Implants Product

Part Number

Description

Diameter

010000874

A

010000875

B

010000876

C

010000877

28 mm

D

010000878

E

010000879

F

010000880

G

010000885

B

010000886

C

010000887

D

010000888

32 mm

E

010000889

F

010000890

G

010000891 010000895

H 10 Degree Face Changing E1 Liner

D

010000896

E

010000897

F

010000898

36 mm

G

010000899

H

010000900

I

010000901

J

010000903

F

010000904

G

010000905

40 mm

H

010000906

I

010000907

J

010000909

H

010000910 010000911

42

Size

44 mm

I J

Implants Product

Part Number

Description

010000980

Diameter 32 mm

010000981

Size B C

010000982

D

010000983

E

010000984

Freedom Constrained E1 Liner

010000985

F 36 mm

G

010000986

H

010000987

I

010000988

J

110003625

28 mm

B

110003616

C

110003621

D

110003626

E

110003619

32 mm

F

110003629

G

110003632

H

110003618 110003634

I

BIOLOX® delta Ceramic Liner

E

110003623 110003628

F 36 mm

G

110003631

H

110003627

I

110003636

G

110003617 110003633

40 mm

H I

43

G7 Acetabular System Implants Product

Part Number

Description

010000994

Apical Hole Plug

010000995

Screw Hole Plug

010000996

6.5 mm x 15 mm

010000997

6.5 mm x 20 mm

010000998

6.5 mm x 25 mm

010000999

6.5 mm x 30 mm

010001000 010001001

44

Size x Length

G7 Low Profile Dome Screw

6.5 mm x 35 mm 6.5 mm x 40 mm

010001002

6.5 mm x 45 mm

010001003

6.5 mm x 50 mm

010001004

6.5 mm x 60 mm

010001005

6.5 mm x 70 mm

Implants Product

Part Number

Description

Diameter

Size/Offset

163666

+12 mm*

163665

+9 mm*

163638

+6 mm

163663

28 mm

+3 mm

163662

Std (0 mm)

163661

-3 mm

163660

-6 mm

163673

+12 mm*

163672

+9 mm*

163674

+6 mm

163670

32 mm

+3 mm

163669

Std (0 mm)

163668

-3 mm

163667

-6 mm

11-363666

+12 mm*

11-363665

+9 mm

11-363664

+6 mm

11-363663

Type 1 CoCr Femoral Head

36 mm

+3 mm

11-363662

Std (0 mm)

11-363661

-3 mm

11-363660

-6 mm

010001031

+12 mm*

010001032

+9 mm

010001033

+6 mm

010001034

40 mm

+3 mm

010001035

Std (0 mm)

010001036

-3 mm

010001037

-6 mm

010001038

+12 mm

010001039

+9 mm

010001040

+6 mm

010001041

44 mm

+3 mm

010001042

Std (0 mm)

010001043

-3 mm

010001044

-6 mm

* Skirted

45

G7 Acetabular System Implants Product

Part Number

Description

Diameter

110025127

+6 mm

110025126

32 mm

110025128 110025129 14-107021 14-107020

+3 mm Std (0 mm) -3 mm +9 mm

Type 12/14 Freedom CoCr Modular Head

14-107019

+6 mm 36 mm

14-107018

+3 mm Std (0 mm)

14-107017

-3 mm

14-107016

-6 mm

110025134

+6 mm

110025130

+3 mm

110025131

32 mm

Std (0 mm)

110025132

-3 mm

110025133

-6 mm

11-107021

Type 1 Freedom CoCr Modular Head

+9 mm

11-107020 11-107019 11-107018

46

Size/Offset

+6 mm 36 mm

+3 mm Std (0 mm)

11-107017

-3 mm

11-107016

-6 mm

Implants Product

Part Number

Description

650-1055

32 mm BIOLOX® delta Option Head

36 mm

650-1058

40 mm

650-1059

44 mm* +6 mm

650-1068 650-1067 650-1066 650-1065

Size/Offset

28 mm

650-1056 650-1057

Diameter

+3 mm

Type 1 Taper Sleeve for BIOLOX® delta Option

0 mm -3 mm

650-1064

-6 mm

650-1063

+7 mm

650-1062 650-1061

+4 mm

Type 12/14 Taper Sleeve for BIOLOX® delta Option

0 mm

650-1060

-3 mm

650-1157

+3 mm

650-1158

28 mm

0 mm

650-1159

-3 mm

650-1160

+6 mm

650-1161 650-1162 650-1163

Type 1 BIOLOX® delta Ceramic Modular Heads

32 mm

650-0661 650-0660

0 mm -3 mm

650-0663 650-0662

+3 mm

+6 mm 36 mm

+3 mm 0 mm -3 mm

*44 mm BIOLOX® delta Option Head is only indicated for ceramic on polyethylene use

47

G7 Acetabular System G7 instrument cases will be shipped with all instruments included under one kit number, unless noted as optional.

B

C

A D L

E G

F

H

I M

J K

110005146 G7 Impaction Instrument Kit (Instruments Included) Product

Label

Part Number

Description

Quantity

A

110018823

Positioning Guide Post

1

110003451

Straight Modular Inserter Handle (must be ordered with 110003452)

1

110003452

Straight Inserter Handle Threaded Shaft (must be ordered with 110003451)

1

C

110003330

Monoblock Hex Screwdriver 3.5 mm

1

D

010002745

Bent Shell Gauge / Suction Cup Handle

1

E

010002736

Ball Hex Driver for Inserter Handles

1

F

110003456

Lateral Positioning Guide

1

010002724

Ball Impactor for 28 mm ID Liners

1

010002725

Ball Impactor for 32 mm ID Liners

1

010002726

Ball Impactor for 36 mm ID Liners

1

010002727

Ball Impactor for 40 mm ID Liners

1

010002728

Ball Impactor for 44 mm ID Liners

1

H

110003454

Curved Inserter Threaded Shaft

2

I

010002723

Face Plate Quick Connect

2

J

110018822

Positioning Guide Rod

1

G

48

110005146 G7 Impaction Instrument Kit (Instruments Included cont.) Product

Label

Part Number

Description

Quantity

K

110003453

Curved Acetabular Shell Inserter

1

110002772

G7 Impaction Instrument Tray (Empty)

1

110010337

G7 Wave Tray Replacement Lid

1

Optional G7 Impaction Instruments Product

Label

Part Number

Description

Quantity

B

110003450

Straight Monoblock Acetabular Shell Inserter

1

L

110003455

Anterior Supine Positioning Guide

1

M

110010571

Sterile Suction Cup (Single use)

1

49

G7 Acetabular System

A

C

B E

D

F H

G I

J

K

110010207 G7 Screw Instrument Kit (Instruments Included) Product

Label

Part Number

Description

A

010002750

Screwdriver Sleeve

B

31-478350

Thread Extractor

C

110003457

Ratcheting Screwdriver Handle

D

110010717

Depth Gauge

E

110003501

Polyethylene Liner Removal Tool

F

110010733

Flexible Drill Shaft

G

110010721

Dual Angle Drill Guide

H

424417

Screw Forceps

I

010002749

Straight Modular Screwdriver 3.5 mm

J

010002748

U-Joint Modular Screwdriver 3.5 mm

K

31-302003

3/8 Shell Extractor

110002771

G7 Screw Instrument Tray (Empty)

110010337

G7 Wave Tray Replacement Lid

Optional G7 Impaction Instruments Product

50

Label

Part Number

Description

010002746

Poly Liner Removal Drill Bit (Single use)

010002751

Poly Liner Removal Screw (Single use)

Note: The following items were sterile validated in the Miscellaneous Bin on the Screw Instrument Tray: Head Provisionals, Liner Provisionals, Liner Provisional Screws

G

H

F E D C

110010224 Patient-Specific Mini Tray Provisional Kit (Instruments Included) Label

Part Number/Color

Description

C

Blue

Size C

D

Green

Size D

E

Purple

Patient-Specific Mini Tray

Diameter/Size

Size E

F

Yellow

G

Grey

Size G

Size F

H

Blue

Size H

110002769

Double Layer Outer Case and Lid

110002770

Patient-Specific Mini Tray Rack (empty)

Detail of contents included on following pages.

51

G7 Acetabular System

A B

C

D

110010212 Micro Size A/B Patient-Specific Mini Tray Product

Label

Part Number

Description

010002611 A

010002612

D

28 mm A Provisional Neutral Liner

28 mm B

010002621

32 mm B

010002713

Size A

B

C

Diameter/Size

Face Plate Impactor 010002714

Size B

010002442

41 mm A

010002444

Provisional Shell

43 mm A

010002446

45 mm B

010002645

28 mm A

010002646

Provisional High Wall Liner

010002655 110004130

28 mm B 32 mm B

G7 Size A/B Provisional Caddy (Empty)

Micro Size A/B Patient-Specific Mini Tray - Optional Instruments Product

Part Number

Description

010002679 010002680

52

010002689

Diameter/Size 28 mm A

Provisional 10 Degree Liner

28 mm B 32 mm B

A

B

C

D

Size C Patient-Specific Mini Tray Product

Label

Part Number

Description

010002613 A

28 mm C Provisional Neutral Liner

010002622 B

010002448

32 mm C Provisional Shell

010002647 C

47 mm C 28 mm C

Provisional High Wall Liner 010002656

D

Diameter/Size

010002715 110002763

32 mm C Face Plate Impactor

Size C

G7 Size C Patient-Specific Mini Tray (Empty)

Size C Patient-Specific Mini Tray - Optional Instruments Product

Part Number 010002681 010002690

Description Provisional 10 Degree Liner

Diameter/Size 28 mm C 32 mm C

53

G7 Acetabular System

A

B

C

D

Size D Patient-Specific Mini Tray Product

Label

Part Number

Description

010002623 A

32 mm D Provisional Neutral Liner

010002630 B

010002450

36 mm D Provisional Shell

010002657 C

49 mm D 32 mm D

Provisional High Wall Liner 010002664

D

Diameter/Size

010002716 110002764

36 mm D Face Plate Impactor

Size D

G7 Size D Patient-Specific Mini Tray (Empty)

Size D Patient-Specific Mini Tray - Optional Instruments Product

Part Number

Description

Diameter/Size

010002614

Provisional Neutral Liner

28 mm D

010002648

Provisional High Wall Liner

28 mm D

010002682 010002691 010002698

54

28 mm D Provisional 10 Degree Liner

32 mm D 36 mm D

A

B

C

D

Size E Patient-Specific Mini Tray Product

Label

Part Number

Description

010002624 A

32 mm E Provisional Neutral Liner

010002631 B

010002452

36 mm E Provisional Shell

010002658 C

51 mm E 32 mm E

Provisional High Wall Liner 010002665

D

Diameter/Size

010002717 110002765

36 mm E Face Plate Impactor

Size E

G7 Size E Patient-Specific Mini Tray (Empty)

Size E Patient-Specific Mini Tray - Optional Instruments Product

Part Number

Description

Diameter/Size

010002615

Provisional Neutral Liner

28 mm E

010002649

Provisional High Wall Liner

28 mm E

010002683 010002692 010002699

28 mm E Provisional 10 Degree Liner

32 mm E 36 mm E

55

G7 Acetabular System

A

C B

D

Size F Patient-Specific Mini Tray Product

Label

Part Number

Description

010002625 A

32 mm F Provisional Neutral Liner

010002632 B

Diameter/Size

010002718

36 mm F Face Plate Impactor

010002454 C

Size F 53 mm F

Provisional Shell 010002456

55 mm F

010002659 D

32 mm F Provisional High Wall Liner

010002666 110002766

36 mm F G7 Size F Provisional Patient-Specific Mini Tray (Empty)

Size F Patient-Specific Mini Tray - Optional Instruments Product

Part Number

Description

Diameter/Size

010002616

Provisional Neutral Liner

28 mm F

010002650

Provisional High Wall Liner

28 mm F

010002684 010002693 010002700

56

28 mm F Provisional 10 Degree Liner

32 mm F 36 mm F

A

C B

D

Size G Patient-Specific Mini Tray Product

Label

Part Number

Description

010002626 A

32 mm G Provisional Neutral Liner

010002633 B

Diameter/Size

010002719

36 mm G Face Plate Impactor

010002458 C

Size G 57 mm G

Provisional Shell 010002460

59 mm G

010002660 D

32 mm G Provisional High Wall Liner

010002667

36 mm G

110002767

G7 Size G Patient-Specific Mini Tray (Empty)

Size G Patient-Specific Mini Tray - Optional Instruments Product

Part Number

Description

Diameter/Size

010002617

Provisional Neutral Liner

28 mm G

010002651

Provisional High Wall Liner

28 mm G

010002685 010002694 010002701

28 mm G Provisional 10 Degree Liner

32 mm G 36 mm G

57

G7 Acetabular System

A B

C D

Size H Patient-Specific Mini Tray Product

Label

Part Number

Description

010002627 A

32 mm H Provisional Neutral Liner

010002634

36 mm H

010002462 B

61 mm H Provisional Shell

010002464 C

Diameter/Size

010002720

63 mm H Face Plate Impactor

010002661 D

Size H 32 mm H

Provisional High Wall Liner 010002668

36 mm H

110004131

G7 Size H Patient-Specific Mini Tray (Empty)

Size H Patient-Specific Mini Tray - Optional Instruments Product

Part Number 010002695 010002702

58

Description Provisional 10 Degree Liner

Diameter/Size 32 mm H 36 mm H

B

A

D C

Macro Size I Patient-Specific Mini Tray Product

Label A

B

Part Number 010002628

Description Provisional Neutral Liner

D

32 mm I

010002635

36 mm I

010002466

65 mm I

010002468 010002470

Provisional Shell

010002472 C

Diameter/Size

010002662 010002669 010002721 110004132

67 mm I 69 mm I 71 mm I

Provisional High Wall Liner

Face Plate Impactor

32 mm I 36 mm I Size I

G7 Size I Patient-Specific Mini Tray (Empty)

Macro Size I Patient-Specific Mini Tray - Optional Instruments Product

Part Number 010002696 010002703

Description Provisional 10 Degree Liner

Diameter/Size 32 mm I 36 mm I

59

G7 Acetabular System

A

B

D C

Macro Size J Patient Specific Mini Tray Product

Label

Part Number

Description

010002629 A

B

32 mm J Provisional Neutral Liner

010002636

36 mm J

010002474

73 mm J

010002476 010002478

Provisional Shell

010002480

75 mm J 77 mm J 79 mm J

010002663 C

32 mm J Provisional High Wall Liner

010002670 D

Diameter/Size

010002722 110010230

36 mm J Face Plate Impactor

Size J

G7 Size J Patient Specific Mini Tray (Empty)

Macro Size J Patient Specific Mini Tray Optional Instruments Product

Part Number

Description

010002697 010002704 010002709

32 mm J Provisional 10 Degree Face Changing Liner

010002712 110003622

60

Diameter/Size 36 mm J 40 mm J 44 mm J

Provisional Ceramic Liner

48 mm J

61

G7 Acetabular System

A

C

D B

10018290 G7 Freedom Provisional Mini Tray 32 and 36 mm Product

Label

Part Number

Description

32 mm B

010002602 010002603

32 mm C

010002604

36 mm D

010002605 A

Diameter/Size

010002606 010002607

G7 Provisional Freedom Constrained Liner

36 mm E 36 mm F 36 mm G

010002608

36 mm H

010002609

36 mm I

010002610

36 mm J

110010729

+6 mm

110010727

+3 mm

110010724

32 mm

110010725 110010728 B

31-127021 31-127020 31-127019 31-127018

62

Offset

STD (0 mm) -3 mm -6 mm

Freedom Provisional Head Type 1

+9 mm +6 mm 36 mm

+3 mm STD (0 mm)

31-127017

-3 mm

31-127016

-6 mm

G7 Acetabular System Instrument Appendix

10018290 G7 Freedom Provisional Mini Tray 32 and 36 mm (cont.) Product

Label

Part Number

Description

C

31-107039

Freedom Plug Removal Tool

110017403 D

Diameter/Size

32 mm Freedom Liner Impactor

110017402

36 mm

110018290

G7 Freedom Provisional Mini Tray (Empty)

Part Number

Description

Optional Instruments Product

Label

Diameter/Size

110010722

+6 mm

110010731

32 mm

110010726 110010723 -

31-137021 31-137020 31-137019 31-137018

Offset +3 mm STD (0 mm) -3 mm +9 mm

Type 12/14 Freedom Provisional Head

+6 mm 36 mm

+3 mm STD (0 mm)

31-137017

-3 mm

31-137016

-6 mm

63

G7 Acetabular System

28 mm

32 mm

36 mm

40 mm (optional)

-6 mm offset

-3 mm offset

0 mm offset

110010211 28/32/36 mm Head Provisional Type 1 Half Tray Kit (Instruments Included) Part Number

Description

110002768

Head Provisional Type 1 Half Tray (Empty)

010002486

+9 mm

010002487

+6 mm

010002488 010002489

28 mm Type 1 Provisional Head

+3 mm Std (0 mm)

+6 mm offset

+9 mm offset

Optional Instruments Part Number

Description

Offset

010002485

28 mm Type 1 Provisional Head

+12 mm

010002492

32 mm Type 1 Provisional Head

+12 mm

010002499

36 mm Type 1 Provisional Head

+12 mm

-3 mm

010002506

+12 mm

010002491

-6 mm

010002507

+9 mm

010002493

+9 mm

010002508

010002494

+6 mm

010002509

+3 mm

010002510

Std (0 mm)

010002511

-3 mm

010002497

-3 mm

010002512

-6 mm

010002498

-6 mm

010002513

+12 mm

010002500

+9 mm

010002514

+9 mm

010002501

+6 mm

010002515

010002490

010002495 010002496

32 mm Type 1 Provisional Head

40 mm Type 1 Provisional Head

44 mm Type 1 Provisional Head

+6 mm +3 mm Std (0 mm)

+6 mm

+3 mm

010002516

Std (0 mm)

010002517

010002504

-3 mm

010002518

-3 mm

010002505

-6 mm

010002519

-6 mm

010002502 010002503

64

Offset

+3 mm offset

36 mm Type 1 Provisional Head

+3 mm Std (0 mm)

110010943 G7 Neutral/High Wall Provisional Liner Pack F-J 40 mm Description

Diameter/Size 40 mm F 40 mm G

Provisional Neutral Liner

40 mm H 40 mm I 40 mm J 40 mm F 40 mm G

Provisional High Wall

40 mm H 40 mm I 40 mm J

110010945 G7 Neutral/High Wall Provisional Liner Pack H-J 44 mm Description

Diameter/Size 44 mm H

Provisional Neutral Liner

44 mm I 44 mm J 44 mm H

Provisional High Wall

44 mm I 44 mm J

65

G7 Acetabular System Instrument Appendix 110010941 G7 10 Degree Micro Provisional Liner Pack A-B 28/32 mm Description

Diameter/Size 28 mm A

Provisional 10 Degree Liner

28 mm B 32 mm B

110010940 G7 10 Degree Provisional Liner Pack C-H 28/32/36 mm Description

Diameter/Size 28 mm C 28 mm D 28 mm E 28 mm F 28 mm G 32 mm C 32 mm D

Provisional 10 Degree Liner

32 mm E 32 mm F 32 mm G 32 mm H 36 mm D 36 mm E 36 mm F 36 mm G 36 mm H

110010942 G7 10 Degree Macro Provisional Liner Pack I 32/36 mm Description Provisional 10 Degree Liner

Diameter/Size 32 mm I 36 mm I

110010944 G7 10 Degree Provisional Liner Pack F-J 40 mm Description

Diameter/Size 40 mm F 40 mm G

Provisional 10 Degree Liner

40 mm H 40 mm I 40 mm J

110010948 G7 10 Degree Provisional Liner Pack H-J 44 mm Description

Diameter/Size 44 mm H

Provisional 10 Degree Liner

44 mm I 44 mm J

66

110010237 G7 Provisional Apical Locking Screw (10 pack) Description Provisional Apical Locking Screw (10 pack)

Single Use Drill Bits Part Number

Description

Size

31-323215

3.2 mm x 15 mm

31-323220

3.2 mm x 20 mm

31-323230

3.2 mm x 30 mm

31-323240 31-323250

3.2 mm x 40 mm

Drill Bit

3.2 mm x 50 mm

31-323260

3.2 mm x 60 mm

31-323270

3.2 mm x 70 mm

31-323280

3.2 mm x 80 mm

Outer Cases Part Number

Description

110002769

Double Layer Outer Case and Lid

110010236

Single Layer Outer Case and Lid

JN444

Aesculap Container

JK489

Aesculap Lid

110010238

Outer Case Replacement Lid

G7 X Ray Templates Part Number

Description

XR010000658-1

G7 PPS /BoneMaster & Finned Xray Template 100%

XR010000658-2

G7 PPS /BoneMaster & Finned Xray Template 110%

XR010000658-3

G7 PPS /BoneMaster & Finned Xray Template 115%

XRAY000162

G7 PPS /BoneMaster & Finned Xray Template 120%

XR110010239-1

G7 OsseoTi Xray Template 100%

XR110010239-2

G7 OsseoTi Xray Template 110%

XR110010239-3

G7 OsseoTi Xray Template 115%

XR110010239-4

G7 OsseoTi Xray Template 120%

67

INDICATIONS 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use. Indications for Biomet G7 Freedom Constrained Liners: The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained Acetabular components have been considered.

68

CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. Contraindications when shell is used with Biomet G7 Freedom Constrained Liner: Bone or musculature compromised by disease, infection, or prior implantation that cannot p ­rovide adequate support or fixation for the prosthesis. For full prescribing information, including Indications for Use, Contraindications, Warnings, Precautions and Possible Adverse Effects, see the package insert and

All content herein is protected by copyright, trademarks and other intellectual property rights owned or licensed to Biomet Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Biomet. This material is intended for health care professionals and the Biomet sales force. Distribution to any other recipient is prohibited. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert and www.Biomet.com. BIOLOX® delta is a trademark of CeramTec AG. This technique was prepared in conjunction with licensed health care professionals. Biomet does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and product(s) for each individual patient. Check for local product clearances and reference product specific instructions for use.

Legal Manufacturer Biomet Orthopedics P.O. Box 587 56 E. Bell Drive Warsaw, Indiana 46581-0587 USA

European Representative Biomet UK, Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK

Biomet UK Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK

www.biometeurope.com

Note: For Ceramic components contained within this Surgical Technique Biomet UK, Ltd is the Legal Manufacturer. ©2015 Biomet Orthopedics • Form No. BMET0120.3-INT • REV0315

www.biomet.com

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