Thousands of patients in the UK have endured severe and prolonged pain due to faulty NexGen knee implants, which were withdrawn from the market in December 2022 by US manufacturer Zimmer Biomet. Despite concerns raised by a surgeon as early as 2014, regulatory bodies were slow to act, leaving an estimated 10,000 NHS patients affected by this defective prosthetic.

Gillian Bodell, a 62-year-old retired police officer, experienced unbearable agony just six weeks after her knee replacement surgery in 2022. Promised a return to normal activity within six weeks by her private orthopaedic surgeon, she instead found herself in constant, severe pain and her knee feeling unstable. It was later revealed she had received a faulty NexGen implant. Gillian, once athletic and enjoying horse riding and long walks, now describes having to 'crawl up the stairs and shuffle down on my bottom – I just can’t live a normal life,' stating her life has been ruined.

The root cause of the NexGen implant's failure was identified as the absence of a crucial surface coating on a component called the tibial tray. This coating, present in earlier NexGen products, helps the implant bond effectively to the leg bones. Without it, the implant could loosen, leading to metal rubbing on bone, causing immense pain and often necessitating further, complex revision surgery. Professor David Barrett, a consultant knee surgeon, noted that this type of implant showed loosening levels two or three times that of normal, describing it as 'remarkably abnormal.'

Concerns regarding the NexGen implants were first communicated to the National Joint Registry (NJR) in 2014 by a worried surgeon, who observed unusually high revision rates. The Medicines and Healthcare products Regulatory Agency (MHRA) was also informed. However, due to a perceived lack of data, no immediate action was taken. Professor Barrett expressed disappointment over the delay, questioning why the NJR took so long to identify the problem despite early warnings. The British Orthopaedic Society has stated that improvements have since been made to the NJR's detection capabilities.

Another patient, Christine Elliott, 73, had a NexGen knee joint implanted in 2018 due to severe osteoarthritis. She suffered grinding pain and slow progress, eventually quitting her job as a healthcare support worker. Almost four years after her initial operation, tests confirmed her implant had become loose and out of position, leading to revision surgery in May 2022. This left her with almost permanent shin pain, impacting her ability to enjoy activities like gardening and long walks.

Revision surgery to correct a faulty implant is not only complex and costly for the NHS, typically between £20,000 and £30,000 per patient, but also rarely yields as good an outcome as the initial successful operation. Patients often face a long and difficult convalescence. Law firms are now representing a growing number of affected individuals considering legal action against Zimmer Biomet. However, product liability law imposes a strict ten-year cut-off point from the implant insertion date, meaning many patients who discovered their problems late may be unable to claim compensation.

Zimmer Biomet stated its commitment to patient safety and acted swiftly to remove the specific tibial component from the market, asserting that the majority of patients had positive outcomes. The MHRA confirmed it began a detailed investigation in 2021 after new data from the NJR emerged, which led to the manufacturer's recall and a subsequent device safety information communication in February 2023.

The NexGen case is not an isolated incident within the medical device industry. Other implants that have faced safety questions include PIP breast implants, withdrawn in 2010 due to industrial-grade silicone and high rupture rates; vaginal mesh implants, which caused traumatic complications and required complex removal surgery for many women; and the Essure contraceptive coil, withdrawn in 2017 amid claims of constant pain, heavy bleeding, and the need for hysterectomies by affected women.