Surgical Technique

PolyAnteverted Liners

Design surgeon list

Smith & Nephew thanks the following surgeons for their participation as part of the R3™ system design team:

Robert Barrack, MDSt. Louis, Missouri

Robert Bourne, MDLondon Health Sciences CenterLondon, Ontario, Canada

Jonathan Garino, MDUniversity of Pennsylvania School of MedicinePhiladelphia, Pennsylvania

Wayne M. Goldstein, MDClinical Professor of OrthopaedicsUniversity of Illinois at ChicagoIllinois Bone and Joint InstituteChicago, Illinois

Richard Kyle, MDMinneapolis, Minnesota

Stephen J. McMahon, MB, BS, FRACS(Orth), FA(Orth)ASenior Lecturer Monash UniversityMalabar Orthopaedic ClinicMelbourne, Australia

John L. Masonis, MDOrthoCarolinaHip & Knee CenterCharlotte, North Carolina

Henrik Malchau, MDAssociate Professor, Harvard Medical SchoolCo-Director, The Harris Orthopaedic Biomechanics and Biomaterials LaboratoryMassachusetts General HospitalBoston, Massachusetts

Michael Ries, MDUniversity of CaliforniaSan Francisco, California

Cecil Rorabeck, MD Professor of Orthopaedic SurgeryUniversity of Western Ontario London, Ontario, Canada

Disclaimer:The following technique is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of treating physicians to determine and utilize the appropriate products and techniques according to their own clinical judgment for each of their patients. For more information on the R3 system, including its indications for use, contraindications, and product safety information, please refer to the product’s label and the Instructions for Use packaged with the product.

Short technique

1. Preoperative planning

2. Acetabular reaming

3. Acetabular trialing

4. Shell insertion

5. Acetabular screw insertion

6. Acetabular poly liner insertion

4

Preoperative X-Rays should include an A/P of the pelvis centered over the symphysis and an A/P and lateral of the affected hip.

Templating can be done on the affected side, but it is important that the contralateral hip also be templated to verify the size.

To ensure a congruent fit, the acetabular component should be medialized to the medial aspect of the acetabulum, as indicated by the teardrop.

The center of rotation also should be marked for subsequent reference.

Acetabular exposure

Complete exposure of the acetabulum is required, regardless of the type of approach. Use the approach with which you are most familiar and achieve the best surgical results.

First, resect the acetabular labrum and place a blunt retractor anteriorly.

After identifying the transverse acetabular ligament, place a blunt retractor around the inferior margin of the acetabulum.

Depending on the exposure, a third retractor can be placed posteriorly following the excision of the labrum.

Remove all overhanging soft tissue and osteophytes in order to visualize the entire acetabular socket.

The acetabulum should be medialized to restore the normal center of hip rotation.

Preoperative planning

Surgical tips:

• To minimize the need of assistance, each of the acetabular retractors can be tied directly to a Charnley retractor.

• Dividing the transverse acetabular ligament will allow reaming to begin inferiorly, preventing the tendency of the reamer to migrate superiorly.

• Removal of soft tissue and overhanging osteophytes from the foveal notch aids visualization of the quadralateral plate and the depth that the acetabulum should be reamed.

Select an acetabular reamer that is considerably smaller than the templated size of the cup. Generally, reaming 6-8mm lower than the templated size is suitable.

Position the initial reamer in a vertical direction (1) to ensure the reamer is taken down to the medial wall.

Direct the second reamer and all subsequent reamers in approximately 45° of abduction and 20° of anteversion for final position of the acetabular component (2).

Preserve subchondral bone to provide good support for the prosthesis. This might mean the reamer will not be medialized all the way to the inner wall. One might suggest leaving some remaining subchondral bone and removing the medial bone that is osteophyte and is covering fatty tissue.

Frequently palpate the posterior and anterior walls of the acetabulum during the reaming process as these walls will determine the largest acetabular size that can be accommodated. Avoid allowing the reamer to drift posteriorly where the bone might be less dense and the path of least resistance for the reamer.

To press-fit an R3™ acetabular shell the acetabulum can either be under-reamed by 1mm or may be reamed line-to-line depending on the bone quality and size of the acetabulum.

Acetabular reaming

5

Surgical tips:

• Each successive reamer must be fully seated within the acetabulum. Failure to do so will result in lateralization of the trial and exposure of the porous coating. If lateralization occurs, go back to a smaller reamer and begin again, checking each size to ensure that the reamers are fully seated.

• Increasing the reamer size by 2mm is recommended, although in smaller patients 1mm increments may be preferred.

• Mark the medial wall with an electrocautery prior to using the last reamer. If the last reamer does not remove the mark, repeat reaming, dropping back a size if necessary.

Instrument tips:

• The acetabular reamer has an open back, which helps visualize reaming and allows easy access to bone chips. This style of reamer is hemispherical and when fully seated it should be covered by the rim of the acetabulum.

• Gently rock reamer handle back and forth approximately 5° for last size used only to ensure rim is accurate for the desired press-fit.

6

After preparing the acetabulum, the trial shell should be inserted to verify size and position of the cup. The surgeon should note the appropriate orientation of the acetabular trial to position the cup correctly.

A trial liner insert cannot be inserted into a trial shell for trial reduction.

If trial reduction using a trial insert is desired at this time, then the preparation of the femur should occur up until the trial reduction stage. The surgeon then has the option of inserting a trial acetabular liner (preferred) in the acetabular implant for subsequent leg length, offset and stability assessments or the real acetabular insert.

Acetabular trialing

Surgical tip:

• The bone at the edge of the trial shell can be marked with an electrocautery to help in final component positioning.

Instrument tip:

• The trial shells are the exact size specified. They can be used to assess the accuracy of reaming or can be press-fit into the acetabulum if using a larger size than the final reamer.

7

Select the appropriate acetabular implant, attach the shell to the cup positioner/impactor and insert it into the acetabulum.

Rotate the X-Bar shaft so that it is in line with the liner removal slot. For the THREE HOLE cup, this positions the three holes in the superior direction. When implanting a MULTI HOLE shell, future access to the liner removal slot should be considered.

Position the X-Bar so that the vertical bar is perpendicular to the long axis of the body and the appropriate crossbar (left or right) aligns with the long axis of the body.

Firmly tap the inserter with a mallet until the cup is fully seated.

Gently toggle the impactor handle to assess the stability and contact of the shell.

Remove the X-Bar, then disengage the impactor handle and look through the impactor hole to judge the distance between the medial wall and the shell.

If the cup is firmly seated, there should be no gap between the shell and the medial wall and no apparent movement in the component.

Acetabular shell insertion

Surgical tips:

• The change in pitch that occurs as the shell is seated against the medial wall is often audible. A depth gauge can be inserted through the screw holes and apex hole to determine the adequacy of shell seating.

• Close attention should be paid to initial positioning of the R3™ shell. However, the use of the slap hammer may be helpful in extracting the shell for repositioning.

Instrument tips:

• The plastic tip on the cup impactor is removable for cleaning, or replacement if damaged.

• The X-Bar references 45° of abduction and 20° of anteversion .

8

Screw fixation is simple, fast and the most common method of assuring additional fixation. Acetabular screws work in compression, which allows the shell to fully seat in the acetabular cavity.

For screw fixation, each screw hole must be predrilled. Using the variable angle drill guide, adjust the angle of the tip to align with the selected screw hole and press firmly in the shell. After drilling the hole, use the depth gauge to verify appropriate screw length(s).

Use the screw forceps to hold the screw. Attach the ball-joint or flexible screwdriver shaft to the end of the screw. Then introduce the screw into the hole and screw it into place using the ratcheting screwdriver handle. Make sure the screw is fully seated within the screw hole so that it will not impinge on the acetabular shell/liner.

Acetabular screw insertion

Surgical tip:

• Screws have been shown to be a reliable method of assuring fixation; however, it is important to avoid neurovascular complications by proper screw placement, avoiding the anterior/superior or anterior/inferior quadrants.

9

A trial reduction should be performed with the final shell and broach in place to appropriately assess head length, stem offset, liner style and position. With XLPE liners, use of ‘skirted’ modular heads should be avoided when possible to maximize range of motion.

Before inserting the R3 acetabular liner, lavage any unused holes and insert the hole covers, if desired. Using the angled hole cover inserter, place screw hole covers over any remaining screw holes and then impact with the peg impactor. Cover the apex hole with the threaded hole cover. Using the straight screwdriver, screw in the hole cover until it stops and is flush with the inner diameter of the shell.

For XLPE liner insertion, screw the appropriate sized liner impactor head on the end of the cup impactor handle and ensure that the tabs on the liner are aligned with the indentions in the shell. Ensure all soft tissue and osteophytes have been removed from the periphery of the shell to avoid interference with the liner lock.

Wipe the shell ID with a lap sponge or gauze until clean and dry. Press the liner impactor firmly until liner is partially locked. Then use light, repetitive impacts with the mallet until the liner is fully seated.

Inspect the liner/shell interface for proper seating. The liner should sit flush with the face of the shell.

R3™ acetabular liner insertion

Surgical tips:

• Running a finger around the circumference of the shell and a visual check will help determine if the liner is flush with the shell face.

• The XLPE liner requires an impaction force between 60 and 120 pounds, increasing with the diameter of the shell.

• The XLPE liner can be removed and repositioned once without compromising the locking mechanism of the liner. To remove R3 liners, insert the liner removal tool fully into the removal slot and pry or impact the liner loose.

• All R3 Anteverted XLPE Liners are lateralized +4mm

Instrument tips:

• The anteverted liner trials are designed with a central screw to facilitate placement. The central screw is tightened into the apex hole of the R3 shell. When using anteverted trial liners it is important that the trial be held firmly in place while using the screwdriver to tighten the screw in the anteverted trial liner into the apex hole of the R3 shell to maintain proper alignment of the anteverted trial liner Align tabs with indentions and tighten into position. Do not force trial.

10

XLPEShells 28 32 36 4044464850525456586062646668707274767880

Shell and R3™ Anteverted liner offerings

XLPEShells 28mm 32mm 36mm 40mm 44mm44

46

48

50

52

54

56

58

60

62

64

66-70mm

72-74mm

76-80mm

Small Outlier Tray

Large Outlier Tray

Core

Tra

y

40m

m T

ray

R3 Anteverted Tray Layouts

11

Poly thickness chart

Shell OD Poly ID

Poly Thickness Taper Region mm

Poly Thickness Load- Bearing Region mm

44 28 5.9 8.146 28 6.8 9.146 32 4.8 7.148 28 7.7 10.148 32 5.7 8.150 28 8.6 11.150 32 6.6 9.150 36 4.6 7.152 28 9.5 12.152 32 7.5 10.152 36 13.3 16.154 28 10.5 13.154 32 8.5 11.154 36 6.5 9.154 40 4.5 7.156 28 11.4 14.156 32 9.4 12.156 36 7.4 10.356 40 5.4 8.360 28 13.3 16.160 32 11.3 14.160 36 9.3 12.160 40 7.3 10.160 44 5.3 8.062 32 12.2 15.162 36 10.2 13.162 40 8.3 11.0

Shell OD Poly ID

Poly Thickness Taper Region mm

Poly Thickness Load- Bearing Region mm

62 44 6.2 9.064 36 11.2 14.164 40 9.2 12.064 44 7.2 10.066-70 36 12.1 15.166-70 40 10.2 13.066-70 44 8.2 11.072-74 36 14.5 17.172-74 40 12.6 15.072-74 44 10.6 13.076-80 36 16.5 19.176-80 40 14.5 17.076-80 44 12.5 15.0

Taper region

Load-bearing

12

Catalog

R3™ NO HOLE Acetabular ShellsSmall Size Shells Standard size shells Large size shellsCat. no. ODmm Cat. no. ODmm Cat. no. ODmm7133-1840 40* 7133-1846 46 7133-1866 667133-1840 42* 7133-1848 48 7133-1868 687133-1844 44 7133-1850 50

7133-1852 527133-1854 547133-1856 567133-1858 587133-1860 607133-1862 627133-1864 64

R3 THREE HOLE Acetabular ShellsSmall size shells Standard size shells Large size shellsCat. no. ODmm Cat. no. ODmm Cat. no. ODmm7133-5540 40* 7133-5546 46 7133-5566 667133-5542 42* 7133-5548 48 7133-5568 687133-5544 44 7133-5550 50

7133-5552 527133-5554 547133-5556 567133-5558 587133-5560 607133-5562 627133-5564 64

R3 MULTI HOLE Acetabular ShellsStandard size shells Large size shellsCat. no. ODmm Cat. no. ODmm7133-8663 48 7133-8673 667133-8664 50 7133-8674 687133-8665 52 7133-8675 707133-8666 547133-8667 56 Jumbo size shells7133-8668 58 Cat. no. ODmm7133-8669 60 7133-8676 727133-8671 62 7133-8677 747133-8672 64 7133-8678 76

7133-0009 787133-0010 80 *Not compatible with anteverted liners

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ID OD

20°+4 XLPE anteverted linerCat. no.

28 44 7133-237128 46 7133-237228 48 7133-237328 50 7133-237428 52 7133-237528 54 7133-237628 56 7137-775628 58 7137-775828 60 7137-7760

32 46 7133-249732 48 7133-2381

32 50 7133-2382

32 52 7133-238332 54 7133-238432 56 7133-238532 58 7133-238632 60 7133-238732 62 7133-2388

36 50 7133-249836 52 7133-240136 54 7133-240236 56 7133-240336 58 7133-240436 60 7133-240536 62 7133-240636 64 7133-240736 66-70 7133-240836 72-74 7133-240936 76-80 7133-2411

R3™ XLPE Anteverted Liners

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Catalog

R3™ XLPE Anteverted Liners (continued)

ID OD

20°+4 XLPE anteverted linerCat. no.

40 54 7133-2499

40 56 7133-241240 58 7133-241340 60 7133-241440 62 7133-241540 64 7133-241640 66-70 7133-241740 72-74 7133-241840 76-80 7133-2419

15

R3™ Trial ShellsStandard size trial shells Small size trial shellsCat. no. ODmm Cat. no. ODmm7136-0745 45 7136-0739 397136-0746 46 7136-0740 407136-0747 47 7136-0741 417136-0748 48 7136-0742 427136-0749 49 7136-0743 437136-0750 50 7136-0744 447136-0751 517136-0752 52 Large size trial shells7136-0753 53 Cat. no. ODmm7136-0754 54 7136-0765 657136-0755 55 7136-0766 667136-0756 56 7136-0767 677136-0757 57 7136-0768 68

7136-0758 58 7136-6524 69

7136-0759 59 7136-6525 707136-0760 607136-0761 61 Jumbo size trial shells7136-0762 62 Cat. no. ODmm7136-0763 63 7136-6526 717136-0764 64 7136-6527 72

7136-6528 737136-6529 747136-6530 757136-6531 767136-2019 777136-2020 787136-2021 797136-2022 80

16

Catalog

ID OD

20°+4 Anteverted trial linerCat. no.

28 44 7133-242728 46 7133-242828 48 7133-242928 50 7133-243128 52 7133-243228 54 7133-243328 56 7133-243428 58 7133-243528 60 7133-2436

32 46 7133-243032 48 7133-2437 32 50 7133-243832 52 7133-2439 32 54 7133-244032 56 7133-244232 58 7133-244332 60 7133-244432 62 7133-2445

36 50 7133-244036 52 7133-247136 54 7133-247236 56 7133-247336 58 7133-247436 60 7133-247536 62 7133-247636 64 7133-247736 66-70 7133-247836 72-74 7133-247936 76-80 7133-2481

R3™ Anteverted Trial Liners

17

R3™ Anteverted Trial Liners (continued)

ID OD

20°+4 Anteverted trial linerCat. no.

40 54 7133-246040 56 7133-248240 58 7133-248340 60 7133-248440 62 7133-248540 64 7133-248640 66-70 7133-248740 72-74 7133-248840 76-80 7133-2489

R3 Liner Impactor HeadsCat. no. Size mm7136-6428* 287136-6432* 327136-6436* 367136-6438* 38-427136-6444* 44-487136-6451* 50-54*Exclusively for liner impaction

R3 MIS InstrumentsCat. no. Description7136-8569 Offset Shell Impactor7136-6052 Offset X-Bar7136-3077 Offset Impactor Tip7136-4073 Offset Reamer Handle

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Catalog

R3™ Straight Shell ImpactorCat. no. 7136-4450

R3 Impactor Replacement TipCat. no. 7136-8570

R3 Depth GaugeCat. no. 7136-4451

X-BarCat. no. MT-2201

Screw ForcepsCat. no. 7136-2298

Ball Joint ScrewdriverCat. no. 7136-2295

R3 Variable Angle Drill GuideCat. no. 7136-4477

Reamer HandleCat. no. 7136-2279

Flexible Screw DrillsCat. no. Length mm7136-2915 157136-2925 257136-2935 357136-2950 50Captured Flexible Screwdriver ShaftCat. no. 7136-2291Captured U-Joint Screwdriver ShaftCat. no. 7136-2292R3 Surgical Templates sizes 40-68 (not shown)Cat. no. 7138-0666R3 Surgical Templates sizes 70-80 (not shown)Cat. no. 7138-1508

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R3™ Trial Liner Removal ToolCat. no. 7136-4455

R3 Liner Removal ToolCat. no. 7136-6021

Hole Cover ImpactorCat. no. 73-2117

Trial Shell HandleCat. no. 7136-2297

Flexible ScrewdriverCat. no. 7136-2290

Ratchet HandleCat. no. 7136-2294

Small Slap HammerCat. no. 7136-7541

Hole Cover InserterCat. no. 73-2133

Straight Screwdriver ShaftCat. no. 7136-2293

Power Adaptors (not shown)Cat. no. 7136-2781 7136-2782 7136-2783

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Catalog

Reamer Domes Small size Standard size Large sizeCat. no. Size mm Cat. no. Size mm Cat. no. Size mm7136-2738 38 7136-2742 42 7136-2765 657136-2739 39 7136-2743 43 7136-2766 667136-2740 40 7136-2744 44 7136-2767 677136-2741 41 7136-2745 45 7136-2768 68

7136-2746 46 7136-2769 697136-2747 47 7136-2770 707136-2748 48 7136-2771 717136-2749 49 7136-2772 727136-2750 50 7136-2773 737136-2751 51 7136-2774 747136-2752 52 7136-2775 757136-2753 53 7136-2776 767136-2754 54 7136-2777 777136-2755 55 7136-2778 787136-2756 56 7136-2779 797136-2757 57 7136-2780 807136-2758 587136-2759 597136-2760 60

7136-2761 61

7136-2762 62

7136-2763 63

7136-2764 64

21

R3™/REFLECTION™ Threaded Hole Cover Cat. no. 7133-6500

Spherical Head ScrewsCat. no. Length mm7133-2515 157133-2520 207133-2525 257133-2530 307133-2535 357133-2540 407133-2545 457133-2550 507133-2555 557133-2560 607133-2565 657133-2570 70

R3 Screw Hole CoverCat. no. 7136-9894

Small Outer CaseCat. no. 7112-9401 (not shown)Lid for Outer CaseCat. no. 7112-9402 (not shown)R3 Trial Shell TrayCat. no. 7136-2213 (not shown)R3 Jumbo Trial Liner Tray Cat. no. 7136-1076 (not shown)R3 Main Instrument TrayCat. no. 7136-2211 (not shown)R3 MIS Instrument Tray Cat. no. 7136-2219 (not shown)R3 Primary Reamer Dome TrayCat. no. 7136-2212 (not shown)R3 CDH Trial TrayCat. no. 7136-1077 (not shown)R3 Disposable Trial ToteCat. no. 7136-0656 (not shown)

22

Catalog

Part Cat. no.R3 Anteverted Liner Core Trial Tray 7133-2461R3 Anteverted Liner Small Outlier Trial Tray 7133-2467

R3 Anteverted Liner Large Outlier Trial Tray 7133-2463

R3 Anteverted Liner 40mm Trial Tray 7133-2464

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Indications

Contraindications

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The R3™ Acetabular System is for single use only and is intended for cementless use.

Caution: US Federal law restricts this device to sale by or on the order of a physician.

1 Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:

a Blood supply limitations

b Insufficient quantity or quality of bone support, e.g., osteoporosis or metabolic disorders which may impair bone formation and osteomalacia

c Infections, osteolysis or other conditions which lead to increased bone resorption

2 Mental or neurological conditions which tend to impair the patient’s ability or willingness to restrict activities

3 Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.

4 Skeletal immaturity

5 The alumina ceramic liner is contraindicated for use with any product other than the metal shell with the correlating inner taper geometry and the appropriate sized alumina ceramic head. The alumina ceramic liner should only be used with the alumina ceramic head. In the US, refer to the separate package insert provided with the ceramic acetabular liners.

6 In revision surgery, inadequate proximal implant support is contraindicated. The literature shows an increased risk of implant failure in revision cases where proximal support is not achieved, poor bone quality exists, and smaller sized implants are utilized. The lower the implant fixation point in the femur (distance from the head center) the greater the risk of implant fracture and/or re-revision.

7 Morbid obesity.

Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation and the prognosis for possible alternative procedures such as non-operative treatment, arthrodesis, femoral osteotomy, pelvic osteotomy, resection arthroplasty, hemiarthroplasty and others.

Conditions presenting increased risk of failure include: osteoporosis, metabolic disorders which may impair bone formation and osteomalacia.

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