Zimmer Biomet Nexgen knee replacement recalled due to high revision rates
A widely used knee replacement system may be banned in the UK, according to media reports.
Posted on 07 December 2022
The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed to the Daily Telegraph that they are investigating concerns raised about the performance of the Nexgen knee replacement components.
The Nexgen product was voluntarily recalled by the manufacturer, Zimmer Biomet, in October this year 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.
Concerns from operating surgeons are reported in the medical literature, with one study in particular noting a 17.6% failure rate at 5 years post-implantation. Concerns mostly arise from loosening of the tibial component, which connects to the bone in the lower leg. Tibial loosening can cause severe pain, inflammation, instability and potentially permanent damage to the surrounding bones and ligaments.
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.
The MHRA can issue a Field Safety Notice, which prohibits an unsafe product from being used in the UK. They are expected to make an announcement soon once their initial investigations are concluded.
Michelle Victor and her team are leading product liability specialists who have successfully pursued complex defective medical device claims against multinational companies. They represent over 600 clients implanted with metal-on-metal hip replacements, and have been instructed in other cases involving allegedly defective hip and knee replacements.
Michelle Victor, product liability partner, 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.”
For more information contact Associate Solicitor Andrew Jackson on 0203 780 0432, or by email (email@example.com)