Latest news with #medicalfailure
BBC News
12-08-2025
- Health
- BBC News
Knee-replacement implant used on thousands of NHS patients known to be faulty for years
A knee-replacement implant, used in thousands of UK operations, was known to have a concerning failure rate eight years before it was finally withdrawn, the BBC has have told File on 4 Investigates how they were left immobile or addicted to painkillers after receiving the NexGen knee implant, because it ended up slipping out of place. Hundreds of people have now had to undergo a second corrective surgeons say the implant's US manufacturer, Zimmer Biomet, took too long to acknowledge there was a problem with one particular Biomet says patient safety is its "top priority" and that its products are approved in accordance with the relevant regulations. Debbie Booker from Southampton had an operation to replace her left knee in initially it appeared to have been successful, she started to experience severe pain a year later while on holiday in Majorca."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 says.A knee replacement involves removing damaged surfaces of the femur (thigh bone) and the tibia (shin bone) and replacing them with artificial says the pain resulted from the knee implant slipping from the tibia and wearing away the the next few months she says she became reliant on prescription painkillers: "I was on fentanyl and morphine. It took me a long time to come off of the morphine because I was addicted."She has since had a second knee replacement, but the problems caused by the initial failed implant have caused long-lasting health problems, she says."It's put my whole body out of alignment, I walk with a limp," says Debbie. As a result, she is now awaiting a hip patient, "Diana" (not her real name), had a knee implant fitted in 2021 which also slipped and started to wear away her shin bone, leaving her virtually immobile."The consultant told me every time I stood up, I was standing on a broken leg. It was absolute agony," she asked to be anonymous as she used to work in the part of their knee replacements, both Debbie and Diana had received a specific implant section, known as a "stemmed option tibial component", also known as a "tibial tray". In broad terms, this section lacked a layer of plastic contained in earlier, well-regarded versions of the NexGen replacement knee. Zimmer Biomet started marketing this modified version in 2012. It was cheaper than the earlier model, so it made financial sense for the NHS, according to Prof David Barrett, a knee specialist at Southampton University."[The NHS] were justified by saying, 'we have every reason to think it'll be fine,'" he the decade that followed, more than 10,000 patients were fitted with this version of the File on 4 Investigates has discovered that concerns were first flagged in 2014 by the National Joint Registry (NJR) which keeps a record of implant surgery across England, Wales and Northern that point, there was insufficient data to draw any reliable conclusions, the NJR told us. It is not an easy task to isolate a specific component that is not working as it should, it added. Further concerns about the implant were raised in Ireland two years later, in 2016, by Prof Eric Masterson, a knee surgeon in Masterson's corrective-surgery rate had soared after he started using NexGen implants in 2012 and he found his professional competence being called into question."That was a lonely place," he tells File on 4 Investigates. "You spend a lifetime building up a career and a reputation, and it's very easy to have that career shredded."When he raised questions with Zimmer Biomet representatives, they assured him there wasn't a widespread problem, he says - an account echoed by NHS surgeons who told us they had found themselves in similar situations. Prof Masterson asked to be put in touch with surgeons in the UK to compare notes. However, confidential internal company documents seen by File on 4 Investigates reveal the company was only willing to contact surgeons on his behalf if they were considered "friends of Zimmer Biomet" and "happy with their NexGen patients".Zimmer Biomet failed to act quickly enough after the problem was identified, according to Prof Leila Biant, one of the UK's leading knee surgeons. She says concerns were raised by herself and other colleagues as far back as 2017."The issue is [the company's] initial reluctance to acknowledge a problem and to not really engage with a process to evaluate these patients until [Zimmer Biomet] got to a situation where they had to," she tells us. 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 the same year, Zimmer Biomet recalled any unused implants from the UK of failure rates for the tibial tray component in this NexGen implant vary from 6% (twice as much as should be expected) to 19%, according to peer-reviewed academic a statement, the company told the BBC: "Zimmer Biomet is committed to the highest standards of patient safety, quality, and transparency. When new data becomes available, we act appropriately, responsibly, and in accordance with applicable regulatory requirements."All 10,000 patients fitted with the problematic implants should now have been recalled for a review by the hospitals where they had their initial operations. Hundreds have already had to have a second operation, and others are likely to follow as problems come to cost of rectifying the problem is not cheap. Each revision costs between £10,000 and £30,000 because the implant is very specialised, says Prof Barrett from Southampton University."Patients are in hospital for a lot longer and they require more support. So this is a very significant expense," he a result, the total bill is estimated to run into millions of Bionet did not respond when File on 4 Investigates asked if it would be contributing to the cost of these operations. However, we have seen a confidential company email, sent in 2022, telling sales staff to say that "Zimmer Biomet will not cover diagnostic, follow-up or revision costs up front".NHS England told us it was "currently reviewing the case involving Zimmer Biomet NexGen knee implants".
Daily Mail
19-05-2025
- Health
- Daily Mail
Family accuse doctors of 'failing' their baby son after inquest told he died of undiagnosed heart condition despite 10 hospital visits
The family of a toddler who died of a rare heart condition have claimed that their son was 'failed' by doctors who did not properly diagnose him. 'Happy' Archie Squire, born on November 20, 2022, was labelled a 'mystery child' by doctors - in reference to his illness - despite making more than 10 visits to A&E in his short life. Presenting symptoms that included constipation, breathlessness and 'failure to thrive', Archie was eventually admitted to Queen Elizabeth the Queen Mother (QEQM) Hospital in Margate, Kent, in November 2023. After suffering two cardiac arrests, he died just two days later. Now, his devastated parents, Lauren Parrish and Jake Squire, have alleged that doctors failed to diagnose his rare heart condition in the lead up to his death, just three days after his first birthday. Following the tragic loss of their son, the couple say that they have endured an 'incredibly painful' journey, made worse by having to wait for answers. At an inquest looking into the circumstances surrounding the young child's death at Oakwood House in Maidstone, Kent on May 19, Archie's emotional family said that words 'can't describe' their experience of watching their son die under such tragic circumstances. They told the hearing they believe there were acute 'failures' in his care, particularly given an inability to diagnose what exactly was wrong with him in the months leading up to his death. The family also alleged that Archie's parents only received 'vague answers' from doctors who failed to diagnose a precise medical issue with their young son. Archie's heartbroken mother, Ms Parrish, explained that her son had struggled with symptoms including constipation, breathlessness, vomiting and 'failure to thrive' - relating to him not gaining weight or growing as expected - throughout his short life. She first took her son to A&E in November 2022, shortly after his birth, when 'grunting' noises he made in his sleep worsened. Though he went on to visit A&E nine more times - being seen by several doctors, GPs and nurses - Ms Parrish said medical professionals described Archie as a 'mystery child' as they were unable to discern what exactly was wrong with him. Shortly after his ninth visit to A&E, the young toddler was again diagnosed with a lower respiratory tract infection by GPs. Archie's mother has now told the inquiry that she believed 'no further investigation' was ever undertaken by medical professionals. On the final hospital visit, a day after Archie's first birthday, and having been 'back and forth' for medical assistance 'so many times', Ms Parrish said that she eventually decided that 'enough was enough'. Archie was then fitted with a nasogastric (NG) tube going into his stomach, which the family believe was a 'main contributing factor' to him going into cardiac arrest, the inquest was told. X-rays were undertaken to check if the tube was in the correct place, and Ms Parrish said that her son's condition rapidly deteriorated following the administration of drugs via the tube on two occasions. On the moments Archie fell into cardiac arrest and resuscitation was attempted, Ms Parrish added: 'It seemed like a lot of what was needed was not available to [medical staff].' Eventually, having been told that young Archie would be severely brain-damaged with a poor quality of life if he was resuscitated, Ms Parrish and Mr Squire agreed to stop CPR. A post-mortem revealed that the toddler had suffered heart failure caused by isolated cardiac ventricular inversion, where the left atrium enters the right ventricle and vice-versa. In a heartbreaking statement released by Archie's family, they said that they believed there had been 'failures to recognise a poorly child not just in the hours leading up to Archie's death, but also in the months before'. Adding that they felt 'lessons are not being learned' and that there was still a lack of 'compassion' for the family's devastating ordeal, the statement read: 'Concerns were raised on many occasions about Archie's breathing. 'We believe there have been missed opportunities to prevent his death. We feel it is our duty to raise these in the form of a complaint, in the hope that no other child dies unnecessarily. 'Archie's parents raised health concerns relating to his breathing. They were often left with vague answers and little treatment which never led to long-term recovery. 'Why weren't parents' concerns listened to on numerous occasions? If he was poorly, why wasn't this recognised?' Archie's parents, Lauren Parrish and Jake Squire (pictured with Archie) , have told an inquest in Maidstone, Kent that they believe there were 'failures to recognise a poorly child not just in the hours leading up to Archie's death, but also in the months before' A statement from Archie's godmother, Nikki Escudier, described the young child him as a 'shining light' that brought 'happiness into the world from the beginning'. Ms Escudier added: 'In just 368 precious days, he filled every moment with warmth, laughter, and the kind of love that stays with you forever. 'His smile lit up the room and his presence left a lasting mark on every heart he touched. 'Though his time with us was heartbreakingly short, he continues to live on. 'Archie was more than a baby. He was a gift, a gentle soul. He brought people together. His sweet nature made him unforgettable. 'Everyone who met Archie felt his charm. He will never get to grow up alongside his brother and we will never get to see the man he would've become. 'Archie Squire made this world brighter simply by being here. And though he is gone, he will always be with us - deeply loved and forever remembered.' During the inquest, Archie's parents are being represented by medical negligence solicitor Lily Hedgman, alongside Leigh Day and barrister Emily Raynor. Ms Hedgman said: 'Archie died just days after his first birthday. His family have shown incredible strength, dignity and resilience throughout this process, motivated by an unwavering determination to ensure that no other family has to endure a similar loss. 'They hope that this inquest will provide a full and transparent account of Archie's care and reveal whether any opportunities to diagnose his heart condition, and therefore avoid his death, were missed.' A spokesperson for East Kent Hospitals University NHS Foundation Trust said: 'We offer our heartfelt condolences to Archie's family and we will work with the coroner to give the family answers.' The inquest, expected to last around eight days, continues.
