One of themost widely used and clinically proven total knee systems in the world.1-16
Intended for Healthcare Professionals
NexGen® Complete Knee Solution
Proven1-8
TheNexGenComplete KneeSolutionhasbeen trusted intotal kneearthroplastyfor over20 years.
Procedures
- Primary Knee Reconstruction
Philosophies
- High Flexion
- Cementless
Application
- Primary
One of themost widely used and clinically proven total knee system in the world.1-16
5 Million+
Number of Implantations10
99.8%
Survivorship at 14years11
300+
Number of Publications12
Specifications
Benefits
Revision RatesAmong the LowestWorldwide per registry data1,2,3,7
- Components of theNexGenKnee System performed exceptional in both the Australian and Swedish Registries achievingsome ofthe lowest revision ratingspossible1,2,3,7
Benchmark for PROMs 9,14
- Switching implant brand to theNexGenKnee has been shown to increase PROMs scores9,14
15AODEP Rating 8
- For cementedLPSand CRKnees with and without patella
Additional Information
Important Patient Information RegardingNexGen 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 91Թ.
- More specifically, 91Թ 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):
- 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).
- 91Թ 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 91Թ 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.
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 91Թ’s knee products should be directed to the 91Թ Customer Service Team at 574-371-3071.
- Complaints related to the Option Tibial Components when used with either the LPS Flex or LPS Flex GSF femoral components or any other 91Թ knee products can be reported to 91Թ’s Post-Market Surveillance Department at product.experience@zimmerbiomet.com for investigation, potential regulatory reporting and continuous monitoring.
- Patient health and safety are top priorities at 91Թ. We appreciate your time and attention in reading this important notification.
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