Latest news with #medical device
Yahoo
12-08-2025
- Health
- Yahoo
Review launched over reports of delayed response to faulty knee replacement part
Health officials have launched a review amid reports that action was not taken swiftly enough following problems with a knee replacement part. BBC's File on 4 reported patients were left immobile and addicted to painkillers due to issues with the joint replacement. 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. 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 has been approached for comment. The company told File on 4 in a statement: '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.'
The Independent
12-08-2025
- Health
- The Independent
Review launched over reports of delayed response to faulty knee replacement part
Health officials have launched a review amid reports that action was not taken swiftly enough following problems with a knee replacement part. BBC's File on 4 reported patients were left immobile and addicted to painkillers due to issues with the joint replacement. 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. 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 has been approached for comment. The company told File on 4 in a statement: '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.'
Yahoo
06-08-2025
- Business
- Yahoo
ZIEN Medical Technologies Achieves CE Mark
SALT LAKE CITY, Aug. 6, 2025 /PRNewswire/ -- ZIEN Medical Technologies ("ZIEN"), a portfolio company of Banner Capital, is pleased to announce achievement of its first CE Mark under the EU MDR (EU 2017/745) on behalf of its customer SAM Medical Products ( Founded in 2009 and based in Salt Lake City, ZIEN is a vertically integrated medical device contract design & manufacturing organization ("CDMO") providing product design & development, manufacturing, cost-down, packaging, sterilization, and quality & regulatory services to medical device companies. As part of ZIEN's capabilities, the ability to act as the "Legal Manufacturer (LM)" or "Manufacturer of Record (MoR)" allows ZIEN to serve as an accelerator to speed innovative technologies to the global market. With ZIEN's EU MDR and MDSAP certifications and ability to serve as LM/MoR technologies that would otherwise take a Medical Device company over 2+ years to reach certification can be brought to market in likely under a year. Combined with ZIEN's other innovative offerings such as packaging and sterilization services the overall combined cost and time savings to reach the market can be significant. SAM Medical Products is an innovator in devices targeted to serve patients undergoing emergency medical procedures. Having provided devices for fracture management, hemorrhage control, and respiratory management SAM Medical entered the Intraosseous Access Market to improve its ability to serve patients in these emergency situations. Having served patients in the USA, Canada, and other global regions SAM desired to reach patients in Europe. Through the existing relationship with ZIEN as a contract manufacturer of the IO products SAM Medical found in ZIEN an opportunity to help expand their capacity and market reach by using ZIEN to provide regulatory support as MoR for the IO product. This allows SAM Medical to focus on expanding other product introductions, and place attention on the market distribution of the IO products while ZIEN manages the ongoing regulatory and engineering support and maintenance of the IO. Kyle Sims, Director of Product Development for SAM Medical stated, "ZIEN's role as Manufacturer of Record allows us to expand our engineering and product support capacity by transitioning the regulatory and technical oversight of this strong IO product line to their team. This partnership enables our internal teams to focus on building out the broader SAM Medical portfolio and gives us a scalable path to deliver more patient solutions as we grow our market presence." Tim Nieman, CEO of ZIEN, remarked "ZIEN has for over 16 years been serving our customers as an integrator of services allowing speed to market for medical devices. The EU MDR has resulted in increased barriers to the introduction of innovative technologies, stifling technology and causing supply bottlenecks. We have seen products that can help patients either be retracted from the EU market or fail to reach the EU due to the expense and complexities of achieving CE mark. ZIEN is pleased to once again be able to help our customers break through these barriers to provide care solutions that might otherwise not reach patients. With the EU MDR and MDSAP certificates and the experienced team here at ZIEN, we are poised to be able to develop, manufacture, and distribute, products that can bring care to patients worldwide while simultaneously reducing the time and expense of doing so. We believe that this service offering reduces the time to global market for a product by up to 2 years and by more than $100,000. Our partnership with SAM Medical allows us to bring the benefits of the SAM Medical IO products to patients in the EU that have to date been unable to have access to this product." Media Contact: Tim Nieman, View original content to download multimedia: SOURCE ZIEN Medical Technologies LLC Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
