Intended for Healthcare Professionals

NexGen^® Complete
Knee Solution

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

Overview Key Data Points Features Related Items Resources Additional Information

Proven^1-8

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

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

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

5 Million+

Number of Implantations¹⁰

99.8%

Survivorship at 14 years¹¹

300+

Number of Publications¹²

Features

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

Explore Products

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

NexGen Trabecular Metal^TM Tibia

Features Monoblock and Modular tibial options for cementless application

NexGen Legacy Constrained Condylar Knee (LCCK)

The NexGen LCCK can be used with augments, stem extensions and Trabecular Metal Cones to help provide stabilization in knee arthroplasty.

X Series^™ Power System

Developed through the shared experience of an international team ofsurgeons and engineers, X Series™ Power System provides a system thatputs you in control.

Zimmer Biomet’s comprehensive assortment of bone cement and products for mixing and delivery, pressurization and bone bed preparation makes for one of the most complete portfolios for Modern Cementing Technique in the market today.

Resources

Education

NexGen® Cruciate Retaining (CR) and Revision Instrumentation Surgical Technique

NexGen® CR-Flex Fixed Bearing Knee Surgical Technique

NexGen® CR-Flex Mobile Bearing Knee Surgical Technique

Additional Information

2020 Swedish National Registry available at http://myknee.se/en/ (Pgs 42 - 43).
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)
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)
Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2020: Table KT2 10 Most Used Femoral Prostheses in Primary Total Knee Replacement
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
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
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
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.

* A minimum cohort of 500 hips/knees at the start of the study (consisting of data from beyond the developing center and from more than three centers/surgeons) with a minimum of 10 years follow-up and an actual revision rate of less than 5%. All deaths, loss to follow-up, failures, and indications for revisions recorded. A maximum of 20% loss to follow-up is permitted.
Baker, et al. The effect of surgical factors on early patient reported outcome measures (PROMS) following total knee replacement. The Journal of Bone and Joint Surgery. 94(B):1058–1066, 2012.
2020 Global sales data available at Zimmer Biomet
Kim, Y.H., et al. Do High-Flexion Total Knee Designs Increase the Risk of Femoral Component Loosening? The Journal of Arthroplasty 32 (2017) 1862-1868.
EMBASE search: «NexGen» AND «Knee».
Kim, et al. Cementless and cemented total knee arthroplasty in patients younger than fifty five years. Which is better? International Orthopaedics (SICOT) 38:297–303, 2014.4.
Partridge, Thomas et al. Improving patient reported outcome measures in total knee replacement by changing implant and preserving the infrapatella fatpad: a quality improvement project. BMJ Quality Improvement Reports 2016; u204088.w3767 doi: 10.1136/bmjquality.u204088.w3767
Kahlenberg, C.A., et al. Comparison of patient-reported outcomes based on implant brand in total knee arthroplasty. Bone & Joint Journal. 2019;101-B (7 Supple C):48–54.
De Steiger, R.N., et al. Lower prosthesis-specific 10-year revision rate with cross-linked than with non-crosslinked polyethylene in primary total knee arthroplasty. Acta Orthopaedica 2015; 86 (6): 721–727.

Important Patient Information Regarding NexGen Stemmed Option Tibial Components

This information is for patients who received a specific type of total knee replacement that was manufactured by Zimmer, Inc.
More specifically, Zimmer, Inc. is conducting a voluntary medical device Field Safety Corrective Action 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):

The femoral component (the product that attaches to your thigh bone);
The tibial tray (the product that fits into your shin bone). This is the recalled part;
The patellar component (the product that fits onto your kneecap); and
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, Inc. 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 Field Safety Notice 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.

Item Number	Device Identifier	Description
00-5986-037-01	00889024218833	NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 3
00-5986-037-02	00889024218840	NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 4
00-5986-047-01	00889024218857	NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 5
00-5986-047-02	00889024218864	NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 6
00-5986-057-01	00889024218871	NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 7
00-5986-057-02	00889024218888	NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 8

Table 2: The item list for the LPS Flex and LPS Flex GSF femoral components can be found here. These products are not recalled.

Item Number	Device Identifier	Description
00-5964-012-01	00889024569157	LPS-FLEX OPTION FEMORAL B-L
00-5964-012-02	00889024569164	LPS-FLEX OPTION FEMORAL B-R
00-5964-013-01	00889024569171	LPS-FLEX OPTION FEMORAL C-L
00-5964-013-02	00889024569188	LPS-FLEX OPTION FEMORAL C-R
00-5964-013-51	00889024001077	LPS-FLEX OPTION FEMORAL C-L
00-5964-013-52	00889024001084	LPS-FLEX OPTION FEMORAL C-R
00-5964-014-01	00889024569195	LPS-FLEX OPTION FEMORAL D-L
00-5964-014-02	00889024569201	LPS-FLEX OPTION FEMORAL D-R
00-5964-014-51	00889024001091	LPS-FLEX OPTION FEMORAL D-L
00-5964-014-52	00889024001107	LPS-FLEX OPTION FEMORAL D-R
00-5964-015-01	00889024405080	LPS-FLEX OPTION FEMORAL E-L
00-5964-015-02	00889024563919	LPS-FLEX OPTION FEMORAL E-R
00-5964-015-51	00889024001114	LPS-FLEX OPTION FEMORAL E-L
00-5964-015-52	00889024001121	LPS-FLEX OPTION FEMORAL E-R
00-5964-016-01	00889024563926	LPS-FLEX OPTION FEMORAL F-L
00-5964-016-02	00889024563933	LPS-FLEX OPTION FEMORAL F-R
00-5964-016-51	00889024001138	LPS-FLEX OPTION FEMORAL F-L
00-5964-016-52	00889024001145	LPS-FLEX OPTION FEMORAL F-R
00-5964-017-01	00889024563940	LPS-FLEX OPTION FEMORAL G-L
00-5964-017-02	00889024563957	LPS-FLEX OPTION FEMORAL G-R
00-5964-017-51	00889024001152	LPS-FLEX OPTION FEMORAL G-L
00-5964-017-52	00889024001169	LPS-FLEX OPTION FEMORAL G-R
00-5764-013-51	00889024192218	LPS-FLEX GSF OPT SZ C-L
00-5764-013-52	00889024192225	LPS-FLEX GSF OPT SZ C-R
00-5764-014-51	00889024192232	LPS-FLEX GSF OPT SZ D-L
00-5764-014-52	00889024192249	LPS-FLEX GSF OPT SZ D-R
00-5764-015-51	00889024192256	LPS-FLEX GSF OPT SZ E-L
00-5764-015-52	00889024192263	LPS-FLEX GSF OPT SZ E-R
00-5764-016-51	00889024192270	LPS-FLEX GSF OPT SZ F-L
00-5764-016-52	00889024192287	LPS-FLEX GSF OPT SZ F-R
00-5764-017-51	00889024192294	LPS-FLEX GSF OPT SZ G-L
00-5764-017-52	00889024192300	LPS-FLEX GSF OPT SZ G-R

Questions regarding the Option Tibial Components or any other Zimmer Biomet knee products should be directed to fieldaction.gscc@zimmerbiomet.com.
Complaints related to the Option Tibial Components when used with either the LPS Flex or LPS Flex GSF femoral components or any other Zimmer Biomet knee product should be directed to ProductComplaintsGSCC@zimmerbiomet.com for investigation, potential regulatory reporting and continuous monitoring.
Patient health and safety are top priorities at Zimmer Biomet. We appreciate your time and attention in reading this important notification.

All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet 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 Zimmer Biomet.

This material is intended for health care professionals. Distribution to any other recipient is prohibited.

For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website.

NexGen® Complete Knee Solution

Proven1-8

Revision Rates Among the Lowest Worldwide per registry data1,2,3,7

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

Number of Implantations10

Survivorship at 14 years11

Number of Publications12