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Responses > Withdrawal of all NexGen Knee Replacement

Freedom of Information request Withdrawal of all NexGen Knee Replacement

Response published: 9 July 2025
Misc

FOI Request

I am a journalist working for BBC Radio 4, writing to request information under the Freedom of Information Act 2000 On 15 February 2023, the Medical and Healthcare Regulatory Agency (MRHA) issued a notice advising of the withdrawal of all All NexGen Complete Knee Solution Stemmed Nonaugmentable Option Tibial Components made by Zimmer Biomet. This was followed by an MHRA notice issued on 15th February 2023 stating that there was a higher revision rate for NexGen knee replacements compared to other knee replacements. They identified the NexGen® Stemmed Option Tibial Components when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Femoral (GSF) Option Femoral. The MHRA advised the patients should be offered additional follow-up. I would like to request the following information under the Freedom of Information Act 2000 From the 15th February 2023 until 13 June 2025: 1. How many patients has your Trust identified that have been implanted with the affected devices? 2. How many of these patients have been notified about this recall? 3. How many of these patients have received a follow up consultation? 4. How many of these patients have received revision surgery? 5. How many of these patients are awaiting revision surgery?

FOI Response

Freedom of Information Request – Ref: FOI 111-2025

Thank you for your recent Freedom of Information request. Please find our response below.

You asked:

On 15th February 2023, the Medical and Healthcare Regulatory Agency (MRHA) issued a notice advising of the withdrawal of all All NexGen Complete Knee Solution Stemmed Nonaugmentable Option Tibial Components made by Zimmer Biomet.

This was followed by an MHRA notice issued on 15th February 2023 stating that there was a higher revision rate for NexGen knee replacements compared to other knee replacements.

They identified the NexGen® Stemmed Option Tibial Components when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Femoral (GSF) Option Femoral.

The MHRA advised the patients should be offered additional follow-up.

I would like to request the following information under the Freedom of Information Act 2000.

From the 15th February 2023 until 13 June 2025:

1. How many patients has your Trust identified that have been implanted with the affected devices?

2. How many of these patients have been notified about this recall?

3. How many of these patients have received a follow up consultation?

4. How many of these patients have received revision surgery?  

5. How many of these patients are awaiting revision surgery?

Our response:

The Trust does not hold the information requested. Please redirect your request to Gloucestershire Hospitals NHS Foundation Trust, at ghn-tr.foi@nhs.net

Next steps:

Should you have any queries in relation to our response, please do not hesitate to contact us. If you are unhappy with the response you have received in relation to your request and wish to ask us to review our response, you should write to:

Louise Moss
Head of Legal Services / Associate Director of Corporate Governance
c/o Gloucestershire Health and Care NHS Foundation Trust
Edward Jenner Court
1010 Pioneer Avenue
Gloucester Business Park
Brockworth, GL3 4AW
E-mail: louise.moss@ghc.nhs.uk

If you are not content with the outcome of any review, you may apply directly to the Information Commissioner’s Office (ICO) for further advice/guidance. Generally, the ICO will not consider your case unless you have exhausted your enquiries with the Trust which should include considering the use of the Trust’s formal complaints procedure. The ICO can be contacted at: The Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.