The Medicines and Healthcare Products Regulatory Agency, which is responsible for ensuring that medicines and medical devices work and are acceptably safe, has confirmed to the Daily Telegraph that they are investigating concerns surrounding the longevity of the NexGen knee replacement components. The NexGen component, manufactured by Zimmer Biomet, is the second most commonly used knee replacement brand in the United Kingdom and is estimated to have been used for over 10,000 patients since 2003.
On 6th December 2022 Biomet issued an urgent medical device recall relating to the NexGen component due to its high rates of revision. The accepted failure rate of knee replacements is set by the National Joint Registry at 3.5%, however, NexGen has been reported to fail in up to 7% of patients after 10 years with one investigation even showing a failure rate as high as 17.6%.
The main concerns surrounding this component is its performance concerning early aseptic loosening of the tibial component which connects to the bone in the lower leg. This can lead to severe pain, inflammation and potential permanent damage to the surrounding bones and ligaments as it causes the implant to rub against the bone.
To correct this, a patient may have to undergo revision surgery to replace the faulty components which poses a higher risk than the original knee replacement as it requires removing the previous implant and replacing it with a larger implant. Knee revision surgeries can often take twice as long and have an increased risk of bleeding and infection, and the recovery period is a much longer process.
The MHRA can issue a Field Safety Notice (FSN) which is a communication to patients about the safety of a medical device and would prohibit its use in the UK if deemed unsafe. The MHRA are expected to make an announcement concerning a FSN once their investigations are complete.
Dr Alison Cave, the MHRA chief safety officer commented to The Daily Telegraph: ‘We are actively working with relevant stakeholders and reviewing all available evidence from a range of sources on the concerns raised on the performance of the NexGen knee implant.’ A spokesperson for the American firm Zimmer Biomet has stated that they are working closely with regulatory authorities and information will be made available on their website soon.
If you feel you may be affected by a faulty knee replacement, or suffered from clinical negligence in another way, please do not hesitate to get in touch for a free consultation via our website or call on 0191 232 8345.