Zimmer recalls NexGen Option Stemmed Tibial Component Size 6 due to higher revision rates when used with specific LPS Flex femoral components in UK joint registry data. Affected patients should consult their surgeon for evaluation.
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
Zimmer is recalling a specific knee implant component because it has higher revision rates when paired with certain other knee implants in UK data. This means some patients might need additional surgery if they received this combination.
The UK National Joint Registry found that this specific tibial component has higher revision rates (surgery to fix or replace the implant) when used with certain femoral components. This means the implant combination may need more repairs than other knee replacements.
Patients who received the NexGen Stemmed Option Tibial Component Size 6 with either LPS Flex or L:PS Flex GSF femoral components during surgery in the UK. Those who received the implant combination are most at risk.
Check if your knee implant has the item number 00-5986-047-02 and is size 6. This component was sold in the UK for unexpired lots.
Your surgeon will determine if you need additional surgery based on the implant combination you received.
The UK National Joint Registry found higher revision rates for this specific tibial component when used with certain femoral components.
No, this is a medical device recall for patients who received the implant during surgery. You should contact your surgeon to discuss next steps.
Look for the item number 00-5986-047-02 and size 6 on your implant. This was sold in the UK for unexpired lots.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-0469-2023 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-0469-2023 from Zimmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
