Zimmer Biomet, the American medical device manufacturer has issued a voluntary recall of more than 10,000 of its ‘NexGen’ knee replacements.
NexGen is the second most popular knee replacement product. It has been used in knee replacement surgeries within the NHS and private hospitals in the UK since 2003. It was formally withdrawn from the UK market in October 2022 following initial investigations by the Medicines and Healthcare Products Regulatory Agency (MHRA). A full investigation is underway.
Whilst implant failure is a recognised complication of all joint replacement surgery the average incidence across all products is approximately 2.4%. However, 350 early failures (within 10 years) have already been reported giving the NexGen implant an unacceptably high failure rate of around 7% with some medical studies suggesting the actual failure rate is higher still as more patients continue to report early failures.
The problem that has been identified relates to the way the joint is cemented into the body. The NexGen device has been found to loosen without any underlying cause in a process known as ‘aseptic loosening’ (failure without infection).
Symptoms of a Faulty Knee Replacement
The common symptoms of device failure that a patient may experience are
- Pain
- Inflammation
- Instability
If left untreated there is a risk of damage to the bone and surrounding tissues, including ligaments and nerves.
Treatment For a Failed Knee Replacement
If your joint replacement has failed it needs to replaced by revision surgery to remove the failed joint and replace it with a new working joint. The operation itself is invasive and carries risks associated with anaesthetic, infection, nerve and tissue damage and poor recovery.
It is generally accepted that the outcome – the level of pain relief and function achieved – is not as good following revision surgery as it is after the first operation.
You Could Be Entitled to Compensation
There is a wide range of potential causes of a poor outcome from surgery. Faulty implants and device failure is one of them..
Each device manufacturer will give instructions on how their implant should be fitted to the body and how its various components should be placed and interact. Failure to place the device in accordance with these instructions could give rise to a medical negligence claim against the surgeon or hospital where surgery was performed.
The burden to prove that the implant was defective or negligently placed rests with the Claimant. We use an experienced team of independent biomedical and medical experts to give evidence on that issue.
If you have experienced problems following knee replacement surgery or any with any other medical device, contact the Ringrose Law Medical Negligence team. Call 01522 561020 or email for a free consultation.