Review launched over reports of delayed response to faulty knee replacement part
Some medics have said they first started noticing issues with a part of a knee replacement made by American medical device company Zimmer Biomet around eight years ago.
A product recall was not issued until December 2022.
A standard total knee replacement has four parts – a femoral component, tibial tray, patellar component and a polyethylene insert.
Concerns were raised about the tibial part – also known as 'NexGen Stemmed Option Tibial Component' – as experts found the implant was linked to higher revision rates compared to other models when it was paired with certain other knee replacement components.
A recall was led by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2022 after analysis of National Joint Registry data.
Leading knee surgeon Professor Leela Biant said action was not taken quickly enough after problems arose.
She told File on 4 that concerns were raised by herself and colleagues around eight years ago – five years before the product recall.
'The issue is their initial reluctance to acknowledge a problem and to not really engage with a process to evaluate these patients until they got to a situation where they had to,' she told the programme.
In June 2022, a study was published in the journal Bone & Joint Open which suggested 'there is a fundamental issue with this NexGen implant design'.
Patients have told the BBC about the impact on their lives.
Debbie Booker, a manager for a company running retirement homes on the south coast, had a knee replacement operation at a local NHS hospital in 2016.
Mrs Booker, from Southampton, described how it initially felt like the operation was a success but a year later she was suddenly 'in agony'.
As a result of the pain she said she had to take powerful pain killers.
'I was on fentanyl and morphine. I was actually addicted to morphine and it took me a long time to actually come off the morphine because I was addicted,' she said.
Medics found the implant had slipped out of place and she needed revision surgery.
Another patient, known only as Diana, described how within three years of her left knee replacement surgery she went from being an active retiree to being sofa-bound.
'Every time I stood up I was standing on a broken leg and it was agony,' she told the programme.
It also impacted surgeons who used the implant during their operations.
One described how they became a surgical 'outlier', with higher revision rates than expected, after using the implant.
File on 4 reported the implant had been used on 10,000 patients.
Local NHS teams are responsible for reviewing and, where clinically necessary, replacing affected implants.
A spokesperson for NHS England said: 'The safety of patients is the absolute priority for the NHS.
'Where issues are identified with any medical device, local NHS teams work swiftly to assess patients and provide replacement treatment where clinically necessary, in accordance with recommendations from the MHRA and device manufacturers.
'NHS England is currently reviewing the case involving Zimmer Biomet NexGen knee implants.'
Zimmer Biomet said in a statement: 'Zimmer Biomet is committed to the highest standards of patient safety, quality, and transparency.
'We issued the Field Safety Notice (FSN) proactively and voluntarily, in consultation with the MHRA, after new UK National Joint Registry (NJR) data indicated the Stemmed Option tibial component was not performing as well when used in combination with two specific femoral components (LPS Flex Option and LPS Flex GSF Option) compared to other combinations of components for which the NJR holds data.
'The vast majority of patients had positive outcomes, and we acted swiftly and responsibly by removing the tibial component from the market to prevent future use in those combinations.
'Zimmer Biomet meets all relevant regulatory requirements and maintains a robust post-market surveillance program.
'All our products are approved in accordance with the relevant regulations, and we continuously monitor the performance of our products once they are available to surgeons.
'Patient safety, transparency, and clinical excellence remain our highest priorities.'
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