Saturday 12 July 2025
Internal Reference Number: FOI_8716
Date Request Received: 16/06/2025 00:00:00
Date Request Replied To: 04/07/2025 00:00:00
This response was sent via: By Email
Request Summary: knee replacements
Request Category: Media
| Question Number 1: 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. https://mhra-gov.filecamp.com/s/d/uNEoJ8FNw6hgKvPL 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. NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003 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? | |
| Answer To Question 1: 0 patients affected, therefore all further questions are Not Applicable. | |
| Question Number 2: How many of these patients have been notified about this recall? | |
| Answer To Question 2: N/A | |
| Question Number 3: How many of these patients have received a follow up consultation? | |
| Answer To Question 3: N/A | |
| Question Number 4: How many of these patients have received revision surgery? | |
| Answer To Question 4: N/A | |
| Question Number 5: How many of these patients are awaiting revision surgery? | |
| Answer To Question 5: N/A | |
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