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庐 Stemmed Option Tibial Components when paired with either the Legacy庐 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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