Latest knee replacement recall sparks media storm

[THE LATEST MEDIA FRENZY regarding joint replacements was sparked in October when US supplier Zimmer Biomet issued a product recall for some variants of its NexGen range of knee replacements.

The national press reported that up to 10,000 of the recalled products had been implanted in UK patients and lawyers Leigh Day reported that the MHRA had confirmed that they are ‘investigating concerns raised about the performance of the NexGen knee replacement components’.

The products concerned were voluntarily recalled after concerns that the components were failing at an unacceptably high rate. The NexGen is the second most commonly used brand of knee replacement used in the UK, and is frequently recommended by NHS surgeons carrying out knee replacements.

Leigh Day warns that: “Patients who have been implanted with faulty knee replacements may have to undergo revision surgery to replace the faulty components with new ones. Patient outcomes from revision surgeries are typically worse than for primary knee replacements, and patients can be left with life-long consequences such as ongoing pain, weakness in the joint, instability and loss of mobility.”

Michelle Victor, product liability partner at the firm, said: “This knee replacement product was very widely used and trusted by many patients and surgeons, with tens of thousands of people in the UK having been implanted with it. The reports of failure rates above 15% are deeply concerning for patients, and should prompt the MHRA to carry out a thorough assessment of whether the NexGen is safe to be used in the UK.

“If you are concerned about the performance of your NexGen knee replacement you should contact your orthopaedic surgeon to investigate. For those whose NexGen knee replacements have already failed, it may be possible to bring legal action.”

The British Orthopaedic Association issued a statement to provide information to patients who may be concerned.

The statement says: “The concerns were identified by the National Joint Registry (NJR) as part of their routine monitoring of implants. The NJR is the largest orthopaedic registry in the world and routinely collects data on hip, knee, ankle, elbow and shoulder joint replacement surgery and monitors the performance of all joint replacement implants.

“If you are worried about your knee replacement with new pain, swelling or limping you should contact your orthopaedic surgeon to discuss. If you do not know what type of knee replacement you have, the NJR have offered a service so you can find out.

“The alert relates to the NexGen Stemmed Option Tibial Component used with either the LPS Flex or LPS Flex GSF Femoral Components. National Joint Registry data suggests that tibial component loosening is a key cause of increased revision surgery. The recommendation is to monitor patients who have had these devices, for any new pain, inability to bear weight, swelling or instability of the knee.” q