Reports Suggest Over 10,000 Patients Could Be Affected By Implant Which Has Been Withdrawn from NHS Use

Patients among thousands given faulty knee replacements have instructed lawyers to investigate their concerns amid reports that over 10,000 patients may be affected.

Specialist lawyers at Irwin Mitchell have been contacted by worried patients who underwent knee replacement surgery with two specific variants of the NexGen total knee replacement implant that were withdrawn from NHS use in October last year.

A legal case is being investigated against the producer of the implants, Zimmer Biomet. On 6 December 2022, Zimmer Biomet initiated a voluntary recall of NexGen Stemmed Option Tibial Components due to ‘clinically and statistically higher overall revision rates.

Knee replacements are usually expected to last at least 15 years and reports suggest many of those given the NexGen product have needed a second operation within 10 years. Concerns have been raised about loosening of the tibial component, with a 17.6 failure rate at 5 years being quoted by one study.

Irwin Mitchell’s clients include a woman from Southampton who has been in constant pain since surgery to replace her left knee with NexGen in September 2017. The resulting pain and mobility issues led to her going into hospital for revision surgery in December 2021 and she has now received a letter from her consultant in relation to her right knee.

Irwin Mitchell is now supporting several patients concerned over the implants, which have been in use since 2003. Media reports suggest seven percent have failed in the last decade, twice the accepted failure rate, with over 350 patients having already needed a second operation.

The annual report of the National Joint Registry of England & Wales has identified that two variants of the NexGen knee implant in question are outliers, in that reported failure rates are significantly outside the expected range.

Expert Opinion

“The patients who have come forward are deeply concerned about reports surrounding NexGen knee replacements. Some have been experiencing pain years since initial surgery and understandably want answers over why they have been left in pain when it appears concerns were raised over NexGen several years ago.

“For those who have been in constant pain, receiving review letters from their consultants has not come as a surprise but the delays have left many needing increased medication and living with reduced mobility.

“We have now been asked to investigate whether the implants our clients received were defective and we’re committed to supporting them as they pursue the answers they deserve. If mistakes have been made, lessons need to be learned to prevent people experiencing avoidable suffering in the future.” Tim Annett - Partner

Case Study – Hampshire

Andrew Hurst, 62, from Southampton was diagnosed with arthritis in his early 30s. Andrew underwent left knee replacement surgery with NexGen in February, 2015 and suffered with a lot of swelling and post-operation pain.

Instead of easing, the pain got progressively worse and he found himself unable to walk without considerable discomfort and as a self-employed carpenter, was unable to continue working.

A letter from Andrew’s consultant to his GP in September 2021 advised that his NexGen implant had failed and also revealed that the NJR were aware of the product’s failings in 2015.

Andrew was finally recalled for revision surgery on his left knee on 9 March 2022 and is hoping to make a full recovery this time and return to work.

Andrew said: “No one goes into hospital to have surgery lightly and having suffered with arthritis for years, I finally made the decision to go for replacement at what I thought was the right time.

“You know there’s going to be some discomfort following knee surgery but the swelling and pain were unbelievable and rather than getting better, only got worse. The result has been seven years of agony and having to give up the job I love.

“The problems with this knee replacement were known about and I think we have a right to know how this was allowed to happen. My life has been ruined for several years and at the very least, I feel people with the NexGen should have been recalled as soon as the problems were known.

“All of us who have been affected deserve the answers and I can only hope that with this new knee, I can start to live my life to the full again and hopefully return to work and re-start my life.”

Case Study - Southampton

Among those who have already contacted Irwin Mitchell is a woman from Southampton who in addition to a failed left knee NexGen implant, has now received a letter from her consultant in relation to her right knee replacement (also a NexGen).

The woman, who works as a learning support assistant in a senior school, went into hospital for her left knee replacement surgery on the NHS on 11 September 2017 and has been on a high dose of painkillers and anti-inflammatory medication ever since, having been in constant pain.

Despite the pain, she was forced to stop taking the anti-inflammatory treatment in March 2021 due to her haemoglobin levels dropping. Four months later in July, she was advised by her consultant that there was a major problem with her left knee implant.

The woman went into hospital again for revision surgery on 1 December 2021. Radiographs revealed characteristic faults, including failure of the implant baseplate. The woman’s faulty NexGen knee replacement has been sent for analysis.

She is now on the list for revision surgery for her right knee and is currently awaiting a date for the operation to take place.

Speaking about her experiences, the woman, 55, who does not wish to be named, said: “The last four years have been a living nightmare and at times it has felt like there would be no end to the pain and that I would be left to face reduced mobility for the rest of my life.

“Prior to the initial surgery I worked full time but this has had to be cut back, as the pain seemed to increase every week that passed. Knee pain impacts your whole life; I can’t manage stairs any more and even sleeping or moving in bed becomes impossible, with every move agony.

“This experience has affected not only my work life, but home life immensely. My family are very active and sporty and I can no longer join in with the fell walking and paddle boarding I used to enjoy so much – leaving me alone or as a spectator at best.

“I knew there was something wrong and thought at first it might be baker’s cysts in my left knee which had popped. Being told there was a major problem with my knee implant in 2021 was a shock, but at least I now had answers as to why I was in so much pain.

“I’m angry because the concerns about NexGen were raised in 2018, yet I and others have had to wait several years in pain to have a fresh operation. In my case, I’m still waiting for a date for corrective surgery for my right knee.

“I and others deserve answers on why we were not advised about these concerns much sooner and have been left with failed implants that have left me living with pain and reduced mobility for years, causing disruption to my life and career. I can no longer use stairs and have had to drop to just a three day week at work having been full time.

“This whole situation has affected me psychologically, not just physically and while no one can prevent arthritis, when you have knee replacement surgery, the least you expect is an improvement to your daily life – not to make things a whole lot worse.”

“I think we have a right to know how this situation was allowed to happen the way it did. Nothing can turn the clock back but those of us affected have waited long enough to have this put right.”

Zimmer Biomet has now advised hospitals and surgeons to stop using the NexGen products in question, and that affected patients should be kept under review with an ‘appropriate index of suspicion for … any new pain, inability to bear weight, swelling or instability of the knee’ according to the recent recall.