NexGen ® Complete Knee Solution

The NexGen Complete Knee Solution has been trusted in total knee arthroplasty for over 20 years.

• Primary Knee Reconstruction

Philosophies

• High Flexion
• Cementless

Application

One of the most widely used and clinically proven total knee system in the world. 1-16

Number of Implantations 10

Survivorship at 14 years 11

Number of Publications 12

System Features

Through an extensive portfolio of options, surgeons have the freedom to select the best component combination for any given patient.

NexGen CR-Flex Fixed Bearing Knee

Designed to help maintain adequate tibio-femoral contact during high flexion

NexGen Gender Solutions ® High-Flex Implants

Designed to accommodate the differences between women’s and men’s knees

NexGen Legacy® LPS-Flex Knee

Designed to enable high-flexion activities

Specifications

Implant Interchangeability

Femoral implant interchangeability with Stemmed Precoat, A/P Wedge and Trabecular Metal tibial components

Cemented and Cementless Options

Cemented and cementless options available for femoral, tibial and patella components

10-20 mm Bearing Sizes

Constraint offering for CR Flex and LPS Flex components

High Range of Motion

Up to 125°-155° Femoral ROM

Benefits

Revision Rates Among the Lowest Worldwide per registry data 1,2,3,7

• Components of the NexGen Knee System performed exceptional in both the Australian and Swedish Registries achieving some of the lowest revision ratings possible 1,2,3,7

Benchmark for PROMs 9,14

• Switching implant brand to the NexGen Knee has been shown to increase PROMs scores 9,14

15A ODEP Rating 8

• For cemented LPS and CR Knees with and without patella

Education

NexGen MIS LPS-Flex Mobile Implant System

NexGen LPS Fixed Bearing Knee

NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knees (U.S Version)

NexGen Prime™ Knee MIS Multi-Reference® 4-in-1 Femoral Instrumentation

NexGen Intramedullary Instrumentation

NexGen Trabecular Metal™ Tibial Tray

NexGen RH Knee Primary/Revision

NexGen LPS-Flex Fixed Bearing Knee

NexGen CR-Flex Fixed Bearing Knee

NexGen Cruciate Retaining (CR) and Revision Instrumentation

Trabecular Metal Primary Patella

MIS Cemented Tibial Component

MIS Multi-Reference 4-in-1 Femoral Instrumentation

MIS Intramedullary Instrumentation

For NexGen Cruciate Retaining & NexGen Legacy Posterior Stabilized Knees

Additional Information

References

1. 2020 Swedish National Registry available at http://myknee.se/en/ (Pgs 42 - 43).
2. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: Table TY2 Cumulative Percent Revision of Primary Total Knee Replacement Prosthesis Combinations with 10 Year Data
   (Primary Diagnosis OA)
3. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: Table FY2 Cumulative Percent Revision of Primary Total Knee Replacement Prosthesis Combinations with 15 Year Data
   (Primary Diagnosis OA)
4. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: Table KT2 10 Most Used Femoral Prostheses in Primary Total Knee Replacement
5. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: Table KT3 10 Most Used Femoral Prostheses in Cemented Primary Total Knee Replacement
6. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: Table KT4 10 Most Used Femoral Prostheses in Cementless Primary Total Knee Replacement
7. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: KT7 Cumulative Percent Revision of Cemented Primary Total Knee Replacement by Prosthesis Combination
8. Latest ODEP ratings can be found at http://www.odep.org.uk, NexGen CR Cem Opt Fixed Stem Std PE no Pat, NexGen CR Cem Opt Fixed Stem Std PE Pat, NexGen CR Unc Fixed Std PE no Pat, NexGen CR Flex Cem Prec Fixed Stem Std PE no Pat, NexGen LPS Unc Fixed Std PE no Pat, NexGen LPS Flex Cem Opt/Prec Fix Stem StdPE no Pat, NexGen CR Flex Cem Prec Fixed Stem HXPE no Pat

ODEP rating received in 2020.

Legal Manufacturer

1800 West Center Street

Warsaw, Indiana 46580 USA

Recall Information for Patients

Important Patient Information Regarding NexGen Stemmed Option Tibial Components when used with the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) Components

• This information is for patients who received a specific type of total knee replacement that was manufactured by Zimmer Biomet.
• More specifically, Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components (“Option Tibial Components”) due to the clinically important higher overall revision rates when these tibial components are used with either the LPS Flex or LPS Flex GSF femoral components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry. For your reference, the item list for the affected Option Tibial Components is provided in Table 1. You may refer to your health care provider or surgery center to obtain your operation implant information records to identify the item numbers.
• To be clear, the LPS Flex and LPS Flex GSF femoral components are not being recalled. Nevertheless, the item list for these products can be found in Table 2.
• Standard total knee replacement has four parts (see Diagram below):

1. The femoral component (the product that attaches to your thigh bone);
2. The tibial tray (the product that fits into your shin bone). This is the recalled part;
3. The patellar component (the product that fits onto your kneecap); and
4. The polyethylene insert (the product that fits between the femoral component and tibial component and acts as the new cartilage for your replaced knee joint).

• Zimmer Biomet voluntarily made the decision to remove the Option Tibial Components. Recent joint registry data from the United Kingdom (https://reports.njrcentre.org.uk) noted that the Option Tibial Components, particularly when paired with either the LPS Flex or LPS Flex GSF femoral components, had higher revision rates than the average revision rate of all other total knee replacements in the registry. More specifically, the NJR provided Zimmer Biomet with a variant report that showed the Option Tibial Components, when combined with both the LPS Flex and LPS Flex GSF femoral components, had both a clinically important higher overall revision rate and a clinically important revision rate for aseptic tibial loosening than other total knee replacements in the registry.
• The UK NJR data suggests that tibial loosening is a key cause of the increased total knee replacement revision for the Option Tibial Components when paired with either the LPS Flex or LPS Flex GSF femoral components. Tibial loosening would typically present as new pain in the knee joint.
• The fact that a patient has a knee component within the scope of this recall does not necessarily mean that the knee component is not functioning well or needs to be replaced.
• Removal of any knee arthroplasty when a patient is not experiencing any symptoms is not recommended.
• Patients implanted with the Option Tibial Components used with either the LPS Flex or LPS Flex GSF femoral components who are not experiencing new or worsening symptoms, should continue normal follow-up with their surgeon or health care provider.
• If you have been experiencing any new pain, inability to bear weight, swelling or instability of the knee, it is recommended that you follow-up with your surgeon or another health care provider for further investigation of the cause of the pain, which could include implant factors as well as patient factors (age, sex, body habitus, activity level, etc.), surgical factors (technique, alignment, cement placement, etc.), and postoperative rehabilitative factors.
• Table 1: The item list for the Option Tibial Components can be found here. These are the recalled products.