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NHS knee replacement known to be faulty eight years before being withdrawn
Thousands of Britons have been forced to undergo corrective surgery after a faulty knee-replacement implant left them in pain and some addicted to painkillers.
Problems started to emerge after US company Zimmer Biomet began using a modified version of its NexGen knee implant in 2012.
The implant was widely used in the NHS because it was cheaper, but patients were soon in excruciating pain after the implant moved, leaving the bone to be worn away.
Debbie Booker from Southampton had an operation to replace her left knee in 2016.
Although the operation was initially seen as a success, she soon began to experience severe pain while on holiday in Majorca a year later.
Her implant – which replaced damaged surfaces of the femur and the tibia with artificial components – had slipped from the tibia and was rubbing against the bone.
'I laid a bag of ice on my knee and for four days I had to do that every few hours because I was in agony,' she told BBC's File on 4 Investigates.
Ms Booker said she soon became addicted to prescription painkillers, such as fentanyl and morphine, to help with the pain.
Even after a second knee replacement, she has been left with health problems.
'Limping and virtually immobile'
'It's put my whole body out of alignment. I walk with a limp,' she said. She is now waiting for a hip replacement.
Another patient said she was left virtually immobile after the implants.
'The consultant told me every time I stood up, I was standing on a broken leg. It was absolute agony,' she told the BBC.
Knee surgeons said Zimmer Biomet had been too slow to acknowledge problems with the implant and to fix them. The company also refused to pay for secondary surgery for patients.
BBC's File on 4 Investigates revealed concerns were first flagged about the implants in 2014 by the National Joint Registry (NJR), which keeps a record of implant surgery across England, Wales and Northern Ireland.
But it said there was insufficient data to draw any reliable conclusions.
In the decade since, more than 10,000 people have been fitted with the modified implant in the UK.
Prof Leela Biant, one of the UK's leading knee surgeons, said Zimmer Biomet failed to act quickly enough after problems were identified. She said she and her colleagues raised issues as far back as 2017.
'The issue is [the company's] initial reluctance to acknowledge a problem and to not really engage with the process to evaluate these patients until [Zimmer Biomet] got to a situation where they had to,' she said.
In 2022, the NJR estimated that patients were nearly twice as likely to need corrective surgery after receiving the NexGen implant, when compared with the average knee implant.
In the same year, Zimmer Biomet recalled any unused implants from the UK market.
The average cost of replacement surgery is between £10,000 and £30,000, with the total bill of fixing the Zimmer Biomet implants expected to run into millions of pounds.
A spokesperson for Zimmer Biomet said the company had 'acted appropriately' when new data became available on the implants.
'[We acted] in accordance with applicable regulatory requirements,' the spokesperson said.
