Having spent three years in pain and unable to lead her normal, active life, Gillian Bodell felt reassured when she went to see a private orthopaedic surgeon about her upcoming knee replacement surgery in 2022.

‘He said I’d be back to normal again within six weeks,’ says Gillian, 62, a retired police officer, who lives with her husband Martin, 67, also an ex-policeman, in Dordon, Warwickshire.

‘And he said the replacement joint involved was one he used regularly – which I took to mean it was a good one, with a good safety record.’ So she was unprepared for what happened next.

Six weeks after the operation Gillian was in unbearable agony that even powerful painkillers couldn’t shift. She says: ‘I’ve got a high pain threshold – I once broke my ankle and carried on working with no plaster cast.

‘I’ve also had a spinal operation for nerve impingement, which was fairly major.

‘So I know all about discomfort after surgery – but the agony I felt in the weeks and months after my knee replacement operation was off the scale. I’d never known anything like it.

‘And my knee felt unstable – I felt right from the start that something wasn’t right.’

Gillian’s instinct was correct. It turned out she had been treated with a faulty NexGen implant.

The prosthetic was withdrawn from the UK market in December 2022 by the US manufacturer, Zimmer Biomet, after the implant was linked to higher revision rates. Studies also revealed that hundreds of patients had been left in constant agony because a component (the NexGen stemmed option tibial component) was coming loose, leaving metal rubbing on bone.

Many have needed further surgery to fix the problems.

Last week it was reported that thousands of NHS patients continued to be fitted with the faulty NexGen joint implants up until their withdrawal in 2022, despite the fact that concerns were raised over their safety by a worried surgeon as far back as 2014.

The surgeon informed the National Joint Registry – a database of joint replacement operations across England, Wales and Northern Ireland – that there seemed to be worryingly high levels of revision rates linked to NexGen knee implants and asked that an investigation should be started.

The MHRA were informed of the potential problem. But no action was taken due to a lack of data.

Law firms have told Good Health that a growing number of those affected are now considering legal action.

The implant, launched in 2012, was the latest in a series of prosthetic knee products from Zimmer Biomet – most of which had a good track record of safety and effectiveness.

But it appears to have differed in one key aspect – it lacked a coating which was a feature of previous NexGen products. This coating was on a part known as the tibial tray, which is in contact with the top of the shin bone and cemented into place.

‘This coating helps the implant bond to bones in the leg – in much the same way as the rough surface on bricks in a wall help them to fix to the surrounding cement properly,’ explains Professor David Barrett, a consultant knee surgeon at Southampton University Hospital.

Without this, the implant was in some cases able to move more than it should, he adds.

‘Other knee implants will occasionally suffer loosening, but this type showed loosening levels two or three times that of normal – it was remarkably abnormal.’

An estimated 10,000 NHS patients have had it implanted.

More than 100,000 people a year have knee replacement surgery on the NHS due to osteoarthritis – where shock-absorbing cartilage inside the joint gets eroded through a process of inflammation and wear and tear.

For the vast majority, it can be life-changing, restoring mobility and easing their pain.

The NexGen implant was used for a total knee replacement, which involves having the lower end of the thigh bone and the upper end of the shin bone replaced with metal and plastic parts. 

For most this provides a long-term solution – according to the National Institute for Health and Care Excellence, 82 per cent of total knee replacements last for 25 years.

‘Every knee implant carries a risk of failure, but that risk is usually extremely small,’ says Oliver Templeton-Ward, a consultant orthopaedic surgeon at Royal Surrey County Hospital.

There are many implants on the market and hospital trusts are free to select which they choose, with most opting for the one with the highest ODEP (Orthopaedic Data Evaluation Panel) ratings – which show that a product has proven quality and longevity. 

Mr Templeton-Ward says at his hospital, as is most often the case, ‘we use ones with ODEP 10A rating or above, which shows they have high-quality evidence to show they have been safe and effective for at least ten years’.

So how did the NexGen implant slip through the net?

Professor Barrett says the original design of the implant was approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but was later modified to remove the surface coating of the stabilising lower part. 

Even then, the National Joint Registry, (NJR) which is meant to detect cases where artificial joints have suspiciously high failure rates, could have acted earlier, he suggests.

‘The issue is why the NJR took so long to identify this when they originally sent a letter to Zimmer in 2014 and yet nothing was actually done until 2022.

He describes the delay in action as being ‘rather disappointing’.

According to the British Orthopaedic Society, a body which represents orthopaedic surgeons, the NJR has already taken steps to improve its detection rates.

‘Over the past decade, improvements in the NJR have enhanced its ability to record multiple variants within implant brands, enabling earlier detection of problems and timely action when a combination shows higher failure rates,’ they said in a statement.

Since the NJR was established in 2003, more than four million people have had artificial joints to replace worn knees, hips, shoulders, ankles and elbows – with the majority being a success. 

However, this isn’t the only implant that has questions hanging over it. Last year the MHRA announced that a replacement hip called the CPT Hip System Femoral Stem would be phased out due its higher risk of fracture (1.4 per cent) than others. And there have been questions over other implants too (see box).

If an implant fails and a patient needs revision surgery, it is costly for the NHS and rarely a good result for patients, Professor Barrett explains. ‘Because of the extent of the damage, replacing a faulty knee is a complex operation and is very costly – between £20,000 and £30,000 per patient.

‘It also requires a long convalescent period. The end result is never as good as if the first operation had been successful.’

Gillian, who needed a revision, can vouch for that. Having previously been athletic, enjoying horse riding and long walks with her dog, now she says: ‘I have to crawl up the stairs and shuffle down on my bottom – I just can’t live a normal life. All my hobbies are things I just can’t do any more. My life has been ruined by this.’

It’s not what she was expecting when, having waited three years on the NHS, she used her private health insurance to have her knee replacement.

She had been ‘determined to make a good recovery’. She did her post-op physio ‘religiously three times a day every day’, she says: ‘But there was no improvement – I was in constant pain.

‘I took strong painkillers, including morphine and tramadol, prescribed by my GP, but it didn’t touch the pain and made me feel sick. I was so listless and drained and felt totally spaced out.’

A few weeks later, at a follow-up appointment with her surgeon, Gillian mentioned she was in terrible pain and her knee felt unstable. An X-ray found nothing wrong.

Months later with the pain even worse the surgeon agreed to do a ‘wash-out’ arthroscopy, where the knee is flushed out with fluid to remove debris and inflammation.

‘But it was no better – I was still walking on crutches or using a walking stick,’ says Gillian.

‘I couldn’t even lift up my leg to put my socks and shoes on.

‘Driving was difficult, which was a problem as my mum was very ill and I couldn’t get over to see her – 45 miles away in Staffordshire – as much as I would have liked.’

By February 2024, almost two years after the operation, the pain in her replaced knee contributed to her having a fall, tearing the cartilage in her good (right) knee – resulting in yet more pain.

‘Finally in June 2024 after X-rays, a bone scan, and an MRI showed that the lower part of the knee joint had become loose, a surgeon agreed to do a revision,’ says Gillian. ‘Unfortunately, even that operation was not a success.’

She remains ‘in limbo, struggling to walk and in constant pain. I just hope I won’t end up in a wheelchair. I hate to think I will – but it is a possibility.’

All patients fitted with the faulty implants should have been contacted by the hospital where they had the operation.

Steve Green, a lawyer at Norwich law firm Fosters Solicitors, told Good Health he has half a dozen UK clients who are pursuing possible legal action against Zimmer Biomet – some of whom had problems ‘within weeks of knee replacement surgery’. 

He says: ‘In some cases, they say their pain and immobility is worse than it was beforehand. The common advice they get from consultants is that it can take six to 12 months to settle down but many end up where they started.’

Some have been in pain for years. However, under product liability law, there is a strict ten-year cut-off point from the date the implant was inserted for taking action.

‘So if you’re a patient who had one of these implants before 2015 but only recently discovered it was the cause of your joint problems, you won’t be able to claim,’ Mr Green told Good Health.

Tim Annett, of law firm Irwin Mitchell, says he has already had to turn away some patients who wanted to seek compensation, as they had the NexGen implant fitted more than a decade ago.

‘It’s a completely inflexible deadline,’ he says. ‘Yet some people may not even realise it was the cause of their problems until after the ten years are up. By then it’s too late.’ The law firm is currently acting on behalf of around 25 patients seeking compensation.

Zimmer Biomet said that it is ‘committed to the highest standards of patient safety, quality and transparency. The 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.

‘Patient safety, transparency, and clinical excellence remain our highest priorities.’

Dr Alison Cave, chief safety officer at the MHRA, said: ‘As soon as we were alerted in 2021 to new data from the National Joint Registry, we began a detailed investigation. This led to the manufacturer issuing a recall of specific NexGen tibial components in December 2022. We further supported this action by issuing a device safety information communication in February 2023.’

IMPLANT WAS LOOSE AND OUT OF POSITION 

Christine Elliott, 73, from Totton, near Southampton, had a NexGen knee joint implanted in her right leg in 2018, when her osteoarthritis got so bad it was making life difficult.

‘I was a healthcare support worker in a busy NHS mental health ward and on my feet nearly all day,’ says Christine, a mother of two and grandmother of three.

‘The pain was grinding – sometimes like a knife was stabbing into my knee – but I tried to grin and bear it.’

A year after going on to the waiting list for a knee replacement, the operation was carried out by a private hospital in Southampton, contracted by the NHS to reduce waiting lists – but it was far from the success she had hoped for.

Christine spent three days in hospital, before being sent home with a programme of rehabilitation to get her new joint moving properly.

But her agony continued.

‘I did everything I was told to, including all the physiotherapy exercises,’ she says.

‘But my progress was slow and I was still suffering a lot of pain in the weeks and months after my surgery.

‘I was taking up to eight paracetamol a day and hardly sleeping because it hurt even to lie in bed, when I wasn’t even putting any weight on it – I was up all night watching Netflix to try and distract myself.’

She blamed her pain on the fact that knee replacement surgery is a major operation and her consultant had warned recovery could be slow. ‘I thought maybe I was just making a fuss,’ says Christine.

‘Friends and neighbours kept telling me about people they knew who had knee ops and were back at work within a couple of months. Yet after six months, I was still off work because I was limping badly and my mobility was so bad. There’s no way I could run around after patients with my knee in that state.’

Christine eventually quit her job. For three years she endured the pain – until a neighbour, an orthopaedic nurse, pressed her to get the knee checked.

She went back to her surgeon, who was mortified to see how much pain she was in.

Tests showed the implant had become loose and out of position and in May 2022, almost four years after her first operation, Christine underwent revision surgery to correct the damage and put in a different joint.

She spent nine days in hospital after having long metal rods inserted into the shin bone and the thigh bone to stabilise the damaged joint.

It’s left Christine with almost permanent pain in the shin, which she fears she may now have for the rest of her life.

‘I used to love gardening and long walks,’ she says. ‘Now I’m in pain and must take paracetamol every day – due to the consequences of having that implant fitted.

‘I had my left knee done in 2024 using a different type of joint, and I have had no trouble from that at all.’

OTHER IMPLANTS THAT FACE SAFETY QUESTIONS 

BREAST IMPLANTS: Nearly 50,000 women in the UK were affected when a breast implant known as PIP, made by French firm Poly Implant Prothese, was withdrawn from sale in 2010 after it was discovered it had been made with unapproved, industrial-grade silicone that was up to six times more likely to rupture than medical-grade silicone.

This caused pain, swelling and disfigurement that often resulted in corrective surgery. Millions of pounds have been paid out in compensation by clinics who supplied them.

VAGINAL MESH: In 2024, more than 100 women in the UK were awarded compensation for traumatic complications suffered after having vaginal mesh implants to treat urinary incontinence.

The polypropylene used to make it began to degrade within months, splintering into parts that pierced some women’s bladders or vaginal walls, with many needing surgery to remove it – a highly complex procedure – and repair the damage it did.

CONTRACEPTIVE COIL: Up to 200 women in the UK are understood to be pursuing legal action against the manufacturer of Essure, a contraceptive implant which some claim has left them in constant pain, suffering heavy bleeding and, in some cases, needing a hysterectomy. 

The coil-like device – withdrawn from sale in 2017 – was a metal insert that blocked a woman’s fallopian tubes to stop sperm reaching her eggs.

Manufacturer, the German firm Bayer, has reportedly paid out more than £1 billion in the US to settle claims from nearly 39,000 women but has not admitted wrongdoing or liability.

Additional reporting: PAT HAGAN AND JO WATERS