Clinical Heritage

LEGION™Total Knee System

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Smith & Nephew has a rich history in the medical field dating back over 150 years. The company has produced many products that demonstrate proven performance. Built upon the world-class GENESIS™ II design and its nearly 20 years of clinical data, the LEGION™ Total Knee System is carrying on the legacy.

LEGIONPrimaryKneeSystem-SafetyandEfficacyClinicalStudy1

• A ten year study spanning five sites and 138 patients. • Two year interim results show just two revisions; one for infection and

one for patella clunk.• LEGION Primary demonstrated excellent implant survivorship of 98.6%.

Samecuttingblocksareusedforbothimplants.ForLEGIONtheblockisputinexternalrotationandforGENESISIItheblockisneutraltotheposteriorcondyles.

LEGIONhassymmetricposteriorcondyleswhileGENESISIIhasathinnermedialposteriorcondyleduetothebuiltinexternalrotation.

Whilethestudyshownaboveisbasedontwo yearinterimresults,theLEGIONTotalKnee Systemhasarichheritagebasedon theGENESISIIDesign.

LEGION and GENESIS II achieve equivalent articulation but do so via different surgical approaches to femoral external rotation.

GENESIS II offers built-in external rotation by having asymmetric posterior condyles whereas LEGION offers surgeon-directed external rotation with symmetric posterior condyles. The differing techniques produce identical implant tibio-femoral kinematics and wear performance.2

When GENESIS II was introduced in 1995, the built-in external rotation was a unique concept and design. It simplified the procedure and surgical technique for primary total knees.

Over time, the need to simplify more complex primary and revision procedures has grown. To address this the implant was modified so that the surgeon could set the external rotation based on patient anatomy, resulting in symmetric posterior condyles. At the same time, the instruments were simplified and a seamless transition to a revision procedure was created leading to the evolution of GENESIS II into the

LEGION Total Knee System.

Built-in Femoral Rotation Surgeon-directed Femoral Rotation

GENESIS II CR GENESIS II PS LEGION CR LEGION PS LEGION RK LEGION HK Cruciate Retaining Knee Posterior Stabilized Knee Cruciate Retaining Knee Posterior Stabilized Knee Revision Knee Hinged Knee

Proven performance, continuous innovation

Knee Class N

Revised

N

Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

Total Knee 13277 386242 1.0 (1.0, 1.1) 2.8 (2.7, 2.9) 3.8 (3.7, 3.8) 4.5 (4.4, 4.6) 5.6 (5.4, 5.7) 6.8 (6.6, 7.0)

2.5%3%3.5%4%

4.5%5%

5.5%

3

National Joint Registry for England, Wales and Northern Ireland, Annual Report 20143

Kaplan-Meier Estimated Cumulative % Probability of Revision at Ten Years

*TRIATHALON and VANGUARD % Probability at eight years only (from 2013 report).

Australian Orthopaedic Association National Joint Replacement

Registry, Annual Report 20144

A 13 year cumulative percent revision is the longest reported outcome for any primary total knee replacement in the Australian Registry. GENESIS II CR CoCr has the lowest cumulative percent revision of all primary total knees with cement fixation at 13 years, 4.6%.

What do the clinical results look like?

NexGenTM

GENESIS™ II CoCr

0%1%1.5%

2%

3.61 2.66 2.982.74

TRIATHLONTMPFC Sigma BicondylarTM

Table KT10: Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation

Femoral

Component

Tibial

Component

N

Revised

N

Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

AGC AGC 146 3451 0.6 (0.4, 0.9) 2.4 (1.9, 2.9) 3.5 (2.9, 4.2) 4.2 (3.5, 5.0) 5.4 (4.6, 6.5) 6.5 (5.3, 8.0)

Active Knee Active Knee 27 1077 0.8 (0.4, 1.6) 2.5 (1.6, 3.9) 3.6 (2.3, 5.5) 4.9 (3.0, 7.9)

Advance Advance II 48 896 1.4 (0.8, 2.5) 4.2 (3.0, 5.8) 5.1 (3.7, 7.0) 6.6 (4.9, 8.8) 8.1 (6.0, 10.9)

BalanSys BalanSys 16 898 0.3 (0.1, 1.0) 1.8 (1.0, 3.4) 2.6 (1.4, 4.6) 3.1 (1.7, 5.6) 4.8 (2.6, 8.8)

Duracon Duracon 377 8971 1.0 (0.8, 1.2) 2.4 (2.1, 2.7) 3.3 (2.9, 3.6) 3.8 (3.4, 4.2) 4.8 (4.4, 5.4) 6.4 (5.5, 7.5)

Evolis Evolis 6 599 0.4 (0.1, 1.5) 1.1 (0.5, 2.7) 1.5 (0.6, 3.3)

Genesis II CR Genesis II 338 11253 0.9 (0.7, 1.1) 2.5 (2.2, 2.8) 3.2 (2.9, 3.6) 4.0 (3.6, 4.5) 4.3 (3.8, 4.8) 4.6 (4.0, 5.3)

Genesis II CR Profix Mobile 24 490 1.7 (0.9, 3.4) 3.2 (1.9, 5.4) 5.0 (3.2, 7.7) 5.9 (3.9, 9.0) 8.0 (5.0, 12.8)

Genesis II Oxinium CR Genesis II 234 5924 1.1 (0.9, 1.4) 2.8 (2.4, 3.2) 3.6 (3.1, 4.2) 4.6 (4.0, 5.3) 6.1 (5.2, 7.2)

Genesis II Oxinium PS Genesis II 493 11510 1.6 (1.4, 1.8) 3.9 (3.5, 4.3) 5.4 (5.0, 6.0) 6.3 (5.7, 6.9) 7.8 (6.8, 9.0)

Genesis II PS Genesis II 419 12395 1.3 (1.1, 1.5) 3.0 (2.7, 3.3) 4.0 (3.6, 4.4) 4.5 (4.0, 5.0) 5.4 (4.7, 6.1) 6.9 (5.0, 9.7)

Journey Journey 161 3132 1.4 (1.0, 1.9) 4.6 (3.9, 5.5) 6.3 (5.4, 7.5) 8.2 (6.9, 9.9)

Kinemax Plus Kinemax Plus 88 1826 0.9 (0.6, 1.5) 2.4 (1.8, 3.3) 3.0 (2.3, 3.9) 3.9 (3.1, 4.9) 4.5 (3.6, 5.7) 8.1 (5.6, 11.6)

LCS CR LCS 269 3936 1.0 (0.7, 1.4) 3.8 (3.2, 4.4) 5.0 (4.4, 5.8) 6.1 (5.3, 6.9) 7.1 (6.3, 8.0) 8.1 (7.2, 9.2)

LCS CR MBT 224 8058 0.7 (0.5, 0.9) 2.2 (1.9, 2.6) 3.2 (2.7, 3.7) 4.1 (3.6, 4.7) 5.4 (4.6, 6.4)

LCS PS MBT 26 452 1.5 (0.7, 3.3) 6.2 (4.2, 9.3)

Legion CR Genesis II 15 573 2.0 (1.1, 3.7) 2.7 (1.5, 4.8)

Legion Oxinium CR Genesis II 19 1537 0.8 (0.4, 1.5) 1.8 (1.1, 2.9) 2.3 (1.3, 4.2)

Legion Oxinium PS Genesis II 80 4020 1.2 (0.9, 1.7) 3.2 (2.5, 4.1) 3.8 (2.9, 5.1)

Legion PS Genesis II 19 2008 0.7 (0.4, 1.2) 1.2 (0.7, 2.0)

Maxim Maxim 33 499 1.2 (0.5, 2.7) 2.6 (1.5, 4.5) 4.7 (3.2, 7.1) 5.2 (3.6, 7.7) 7.0 (4.8, 10.1)

Natural Knee Flex Natural Knee II 15 787 0.8 (0.4, 1.8) 2.5 (1.5, 4.3) 3.4 (1.8, 6.4)

Natural Knee II Natural Knee II 43 1678 0.4 (0.2, 0.8) 1.3 (0.8, 2.0) 1.9 (1.3, 2.8) 2.9 (2.1, 4.0) 3.8 (2.7, 5.3)

Nexgen CR Nexgen 97 3535 0.4 (0.3, 0.7) 1.3 (1.0, 1.8) 1.7 (1.3, 2.2) 2.0 (1.6, 2.6) 2.7 (2.2, 3.4) 5.5 (3.9, 7.6)

Nexgen CR Flex Natural Knee II 3 581 0.3 (0.1, 1.4) 0.6 (0.2, 2.0)

Nexgen CR Flex Nexgen 152 11390 0.6 (0.5, 0.8) 1.3 (1.1, 1.6) 1.9 (1.6, 2.3) 2.2 (1.8, 2.6)

Nexgen LCCK Nexgen 19 449 1.9 (1.0, 3.8) 3.8 (2.2, 6.3) 5.4 (3.3, 8.9) 5.4 (3.3, 8.9)

Nexgen LPS Nexgen 193 5118 1.0 (0.7, 1.3) 2.2 (1.8, 2.7) 2.9 (2.4, 3.4) 3.7 (3.2, 4.3) 4.7 (4.1, 5.4) 5.6 (4.7, 6.7)

Nexgen LPS Flex Nexgen 637 21737 0.9 (0.8, 1.0) 2.4 (2.2, 2.6) 3.3 (3.0, 3.6) 4.2 (3.8, 4.5) 5.3 (4.8, 5.8)

Optetrak-PS Optetrak 133 2078 1.6 (1.1, 2.2) 5.0 (4.1, 6.1) 6.9 (5.8, 8.3) 8.4 (7.0, 10.0) 10.4 (8.3, 13.1)

Optetrak-PS Optetrak-RBK 32 567 2.0 (1.1, 3.6) 4.8 (3.3, 7.1) 6.6 (4.6, 9.4) 7.4 (5.1, 10.7)

PFC Sigma CR MBT 20 1061 0.6 (0.3, 1.3) 1.4 (0.8, 2.4) 1.8 (1.1, 3.0) 2.3 (1.4, 3.7) 3.0 (1.7, 5.2)

PFC Sigma CR PFC Sigma 219 9584 0.8 (0.7, 1.0) 1.9 (1.6, 2.2) 2.4 (2.1, 2.8) 3.0 (2.6, 3.5) 4.0 (3.3, 4.8)

PFC Sigma PS MBT 159 5219 0.8 (0.6, 1.0) 2.6 (2.2, 3.2) 3.5 (3.0, 4.1) 4.2 (3.5, 5.0) 4.7 (3.9, 5.8)

PFC Sigma PS PFC Sigma 171 6238 1.1 (0.8, 1.4) 2.4 (2.0, 2.8) 2.9 (2.5, 3.4) 3.1 (2.7, 3.7) 4.2 (3.5, 5.2)

Profix Profix 133 3285 1.1 (0.8, 1.5) 2.6 (2.1, 3.2) 3.2 (2.7, 3.9) 4.0 (3.4, 4.8) 4.8 (4.0, 5.7) 4.9 (4.1, 5.9)

Profix Oxinium Profix 76 999 1.9 (1.2, 3.0) 5.1 (3.9, 6.7) 6.9 (5.4, 8.7) 7.9 (6.3, 9.8) 8.5 (6.8, 10.6)

RBK RBK 53 1890 0.9 (0.5, 1.4) 2.7 (2.0, 3.7) 3.4 (2.5, 4.5) 3.5 (2.6, 4.7) 5.2 (3.4, 8.1)

Scorpio CR Series 7000 77 1757 0.9 (0.5, 1.4) 2.3 (1.7, 3.1) 3.0 (2.3, 3.9) 4.1 (3.2, 5.2) 5.1 (4.0, 6.4) 6.4 (4.8, 8.4)

Scorpio NRG CR Series 7000 16 964 0.8 (0.4, 1.6) 1.4 (0.8, 2.5) 1.8 (1.1, 3.0)

Scorpio NRG PS Series 7000 43 2416 0.6 (0.4, 1.0) 1.9 (1.4, 2.6) 2.6 (1.9, 3.6)

Scorpio PS Scorpio 29 510 1.2 (0.5, 2.6) 3.8 (2.5, 5.9) 4.4 (2.9, 6.7) 5.4 (3.7, 7.8) 6.7 (4.6, 9.7)

Scorpio PS Scorpio+ 53 900 1.2 (0.7, 2.2) 4.0 (2.9, 5.5) 5.7 (4.3, 7.4) 6.2 (4.7, 8.0) 6.4 (4.9, 8.4)

Scorpio PS Series 7000 131 3057 1.1 (0.8, 1.5) 2.9 (2.3, 3.6) 3.9 (3.2, 4.7) 4.9 (4.1, 5.9) 7.1 (5.7, 8.8)

Triathlon CR Triathlon 304 16914 0.8 (0.7, 1.0) 2.1 (1.9, 2.4) 2.8 (2.4, 3.1) 3.1 (2.7, 3.6)

Triathlon PS Triathlon 122 4118 1.6 (1.2, 2.0) 3.1 (2.6, 3.8) 3.9 (3.2, 4.8) 4.7 (3.7, 5.8)

Vanguard CR Maxim 75 4447 0.6 (0.4, 0.9) 2.1 (1.7, 2.8) 2.9 (2.3, 3.8) 3.4 (2.5, 4.5)

Vanguard CR Vanguard 7 681 0.5 (0.2, 1.6) 1.6 (0.7, 3.4) 1.6 (0.7, 3.4)

Vanguard PS Maxim 118 2692 1.9 (1.4, 2.5) 5.0 (4.1, 6.0) 6.0 (5.0, 7.3) 7.4 (5.6, 9.6)

Other (168) 414 8914 1.4 (1.1, 1.7) 3.9 (3.4, 4.4) 5.6 (5.0, 6.2) 7.0 (6.3, 7.7) 8.5 (7.6, 9.4) 9.5 (8.5, 10.6)

TOTAL 6606 207071

Note: Some cementless components have been cemented.

Only combinations with over 400 procedures have been listed.

Genesis II CR Genesis II 338 11253 0.9 (0.7, 1.1) 2.5 (2.2, 2.8) 3.2 (2.9, 3.6) 4.0 (3.6, 4.5) 4.3 (3.8, 4.8) 4.6 (4.0, 5.3)

Femoral

Component

Tibial

Component

N

Revised

N

Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

3.41

VANGUARDTM

Table KT10: Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation

At 13 years, the cumulative percent revision of primary total knee replacement undertaken for osteoarthritis is 6.8%5

Table KT11: Cumulative Percent Revision of Primary Total Knee Replacement (Primary Diagnosis OA)

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5 – 8 Year Results8

• 98.9% survivorship at a mean follow-up of 77.6 months and 98.2% “excellent” or “good” results based on self reported patient satisfaction outcomes

• Consecutive series of 562 knees• Mean post-op ROM 118.6°• Average post-op Knee Society Scores 93.4

5 Year Follow-up of First 100 cases9

• Survivorship 98.8% at 5 years• Mean flexion 118°• 100% “excellent” or “good” results post-op Knee

Society Score

GENESIS II: A Systematic Literature Review of Clinical Outcomes7

• Data analysis from 12 studies showed a Kaplan-Meier survival rate of 99.5% at 5 years, 99.9% at 7 years; 98.8% at nine years

• 1 study reported a Kaplan-Meier survival rate of 96% at 11.9 years

• Includes 19 studies total and 2656 knees• Mean postop Knee Society score of 90.6

15 – 17 year GENESIS™ II Clinical Results6

• “Excellent” survivorship of 98.1% at a minimum follow-up of 15 years

• 89 consecutive GENESIS II knee procedures were studied

• “Minimum 15-year follow-up reports after TKA are not abundant”

Minimum 10 Year Follow-up10

• “Excellent” survival rate of 97.8% at 10 years• 98 TKAs with oxidized zirconium femoral component• “Good clinical and radiological outcomes”

5-year Results of an Oxidized Zirconium Femoral Component for TKA11

• Survival rate of 98.7% at 7 years• 98 TKAs with oxidized zirconium femoral component• Mean post-op knee society score of 89

Oxidized zirconium femoral component for TKA: A follow-up note of aprevious report at a minimum of 10 years

Massimo Innocenti, Fabrizio Matassi ⁎, Christian Carulli, Lorenzo Nistri, Roberto CivininiOrthopedic Clinic, Department of Special Surgical Science, University of Florence, CTO-Largo Palagi 1, 50139 Florence, Italy

The Knee 21 (2014) 858–861

Contents lists available at ScienceDirect

The Knee

5

LateralizedanddeepenedtrochleargrooveFemoral components have an “S-curve” trochlear groove that, like the natural femur, gently moves the patella from a lateral position in extension towards the midline in flexion. This has shown to reduce lateral release rates to ~3%12 compared to ~14%13 for competitive systems. The patella groove has been distally extended to provide full patellofemoral contact throughout the ROM.

BoneConservingPSBoxLess bone is removed with the femoral components compared to competitive systems,14 leaving the critical anterior bone bridge intact for stability and strength.

AsymmetricbaseplateforbettertibialcoverageThe asymmetric shape matches the anatomy of the tibia,15 eliminating the need to undersize which can lead to uncovered bone or oversize which can lead to baseplate overhang. Additionally, maximizing tibial coverage through asymetric baseplate has also been shown to minimize tibia rotational errors.16

Mid-flexion Patella position

GENESIS II/LEGION™ Otherkneesystems

Oversized Symmetric Baseplate Posterior-Lateral Overhang

Undersized Symmetric Baseplate Posterior-Medial Uncovered

Anatomic Baseplate Full Coverage with No Overhang

Why do LEGION™ and GENESIS™ II have such good results?

The clinical results of LEGION and GENESIS II can in large part be attributed to unique design features working together to produce a world class knee implant.

CRHighFlexinsertPSHighFlexinsert

VERILAST™TechnologyforwearreductionVERILAST Technology is the bearing couple of OXINIUM™ Oxidized Zirconium and XLPE which has completed wear testing 9 times the industry standard17 and shown

exceptional wear performance. VERILAST Technology incorporates proprietary OXINIUM alloy. Compared to cobalt chrome, OXINIUM alloy has much less cobalt (<0.002%), chromium (<0.02%) and nickel (<0.0035%) content.

Highlypolishedbaseplateforbackside wearreductionLEGION baseplates have a proven locking mechanism with an anterior and posterior dovetail to reduce micromotion and are composed of highly polished titanium to decrease backside wear.18

FlexionfriendlyTightly radiused posterior condyles allow for deeper flexion without the risk of edge loading or excessive collateral ligament tension. The PS and CR High Flex inserts support flexion up to 155°. One study by Dr. Laskin showed a mean ROM of 118º five years postoperatively.19

LEGION encompasses the same design features that have demonstrated long-term survivorship with GENESIS™ II. LEGION CR and PS knees provide the same kinematic motion and articulation as GENESIS II with the addition of updated instrumentation and a seamless total knee system able to handle all stages of knee reconstruction.2

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The legacy continues with LEGION™

Updatedinstruments

LEGION is not only offered with updated traditional

instrumentation but also with a more cost-effective and simplified approach to total knee arthroplasty. VISIONAIRE™ FASTPak includes VISIONAIRE Cutting Guides and size-specific disposable instruments.

The surgeon has confidence that he will have new, sterile instruments specific for each patient and the OR staff can have confidence that setup, surgery and cleanup will

be simple with minimal time commitment. 20

VISIONAIREFASTPak

LEGION has the flexibility to address diverse surgical challenges and simplify decision making interoperatively. The LEGION instrumentation gives you the ability to move from a cruciate retaining implant all the way to a hinged component.

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LEGION™ offers peace of mind

Seamlesssystem

SameA-PResectionAddPSBoxAddAugmentsAddConstraint

SameA-PResectionAddRevisionComponents

SameA-PResectionwithBuild-upAddHingeComponents

Today’s orthopaedic environment demands simple solutions with proven clinical history. With the durability of VERILAST™ Technology, inter-operative flexibility

of both implants and instrumentation, and a rich clinicalheritage – the LEGION Total Knee System gives surgeons peace of mind not only in the OR but with the knowledge that their patients will successfully return to their active lifestyles.

©2015 Smith & Nephew, Inc. All rights reserved.02961 V1 02/15

Smith&Nephew,Inc.1450 Brooks RoadMemphis, TN 38116USA

Telephone: 1-901-396-2121Information: 1-800-821-5700Orders/inquiries: 1-800-238-7538

www.smith-nephew.com

™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All trademarks acknowledged

References

Proven performance, continuous innovation

1. LEGION™ Primary Knee System: A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION Primary Knee System for Primary Total Knee Replacement in Subjects with Degenerative Knee Disease. 10-K300-95301, 29 April 2014. Version 1.0.

2. Smith & Nephew Technical Memo TM-11-013A Comparison of LEGION and GENESIS™ II OXINIUM Femoral Designs3. National Joint Registry for England, Wales, and Northern Ireland, 11th Annual Report, 2014, Table 3.22; Kaplan-Meier estimated

cumulative percentage probability of first revision (95% CI) of a primary total knee replacement by main type of implant brand at the indicated number of years after primary operation.

4. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2014 Table KT10: Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation.

5. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2014 Table KT11: Cumulative Percent Revision of Primary Total Knee Replacement (Primary Diagnosis OA)

6. Victor J, Ghijselings S, Tajdar F, Van Damme G, Deprez P, Arnout N, Van Der Straeten, Total knee arthroplasty at 15-17 years: does implant design affect outcome? C., Int Orthop. 2014 Feb;38(2):235-41

7. Bhandari, Saccone, Sprague, “The GENESIS II Total Knee System in Primary Total Knee Arthroplasty: A Systematic Literature Review of Clinical Outcomes”, Bone&Joint Outcome, Vol 01, No 01-Augut 2011.

8. S&N literature 40422802 02/06.9. Laskin, Richard S. and Davis, John. “Total knee replacement using the GENESIS™ II prosthesis: a 5–year follow up study of the first 100

consecutive cases”, The Knee, 2004, July.10. M. Innocenti, et al, “Oxidized zirconiumfemoral component for TKA: A follow-up note of a previous report at a minimum of 10 years,”

Knee (2014).11. M. Innocenti, R. Civinini, C. Carulli, F. Matassi, M. Villano “The 5-year Results of an Oxidized Zirconium Femoral Component for TKA,”

Clin Orthop Relat Res (2010) 468:1258–1263.12. Laskin, Richard S., Davis, John, “Total Knee Prosthesis using the GENESIS II Prosthesis: a 5-year follow-up study of the first 100

consecutive patients,” The Knee ,12 2005, pp. 163-167.13. Yang C.C., McFadden L.A., Dennis D.A., Kim R.H., Sharma A., “Lateral retinacular release rates in mobile versus fixed-bearing TK,” Clin

Orthop Relat Res, Nov 2008; 466(11), pp. 2656-61.14. Haas, S.D.; Nelson, C.L.; Laskin, R.S. Posterior Stabilized Arthroplasty: An Assessment of Bone Resection. The Knee 7 (2000) 25-29.15. Westich, GH; Laskin, RS; Haas, SB; Sculco, TD: Resection Specimen Analysis of Tibial Coverage in Total Knee Arthroplasty. Clinical

Orthopaedics and Related Research, #309, December 1994.16. Stacey Martin MD, Alex Saurez BS, Sabir Ismaily BS, Kashif Ashfaq MD, Philip Noble PhD, Stephen J. Incavo MD, Maximizing Tibial

Coverage Is Detrimental to Proper Rotational Alignment, Clin Orthop Relat Res (2014) 472:121–125.17. ISO 14243-318. Todd, Dwight, et. al., Orthopedic Abstract, “The Effect of Tibial Tray Surface Roughness and Insert Micromotion on Backside Wear.”

Smith & Nephew, Memphis, TN19. Laskin, Richard S. and Davis, John. “Total knee replacement using the GENESIS™ II prosthesis: a 5–year follow up study of the first 100

consecutive cases”, The Knee, 2004, July.20. VISIONAIRE FastPak Instruments Messaging Brochure, S&N literature 02897 V1 01/15.