ENGLAND — More than 10,000 patients have been given a faulty knee replacement which doubles he risk of joint failure, The Telegraph London can disclose.
Implant has twice accepted failure rate with potentially catastrophic consequences for patients, particularly the elderly
The implant, which has been in use since 2003, was withdrawn from the market by its manufacturer in October.
The Telegraph has learnt that UK health regulator the Medicines and Healthcare products Regulatory Agency (MHRA) is now preparing to issue a field safety notice, prohibiting its use.
Available across multiple NHS trusts, the implant, manufactured by Zimmer Biomet, a US firm, has been shown to fail in up to seven per cent of patients after ten years – twice the accepted failure rate of 3.5 per cent set by the National Joint Registry.
One study found the failure rate to be much higher at 17.6 per cent – more than five times as high as the accepted level.
This can have catastrophic consequences for patients, many of whom are elderly, as undergoing a second knee replacement operation poses a much greater risk.
The knee replacement, called the Nexgen, is part of a family of Zimmer Biomet implant devices with 88 possible variants. In total, these have been given to over 183,000 people in England, Wales and Northern Ireland, and more than five million worldwide. Of these variants, three combinations have been proven to place patients at a dangerously high risk of joint failure.
READ FULL STORY BY CAMERON HENDERSON IN THE TELEGRAPH, LONDON: