More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup

April 16, 2012 By MassDevice staff

Regulators in the U.K. and New Zealand are warning again about higher-than-expected revision rates for certain metal-on-metal total hip replacement systems that use a combination of components made by Johnson & Johnson‘s (NYSE:JNJ) DePuy Orthopedics division and Stryker (NYSE:SYK).

The Medicines & Healthcare products Regulatory Agency, an executive agency of the U.K. Dept. of Health, issued a warning yesterday about elevated revision rates for Mitch TRH acetabular cups and Mitch TRH modular heads manufactured by DePuy’s Finsbury Orthopaedics unit when used in combination with uncemented Accolade femoral stems manufactured by Stryker Orthopedics.

The revision rate for a less-invasive procedure using the Mitch TRH device, called hip resurfacing arthroplasty, fall in line with guidance, according to the regulators.

"But that the cumulative revision rate for Mitch TRH System total hip replacements (revision rate of 8.8% at 4 years based on 445 patients recorded by the NJR) is higher than indicated as acceptable by the National Institute for Health and Clinical Excellence," according to the agency.

A further analysis of the data by DePuy found that revision rates varied considerably depending on the type of femoral system being used, according to the report, and that the Mitch TRH with un-cemented Accolade had a revision rate of 10.7% after 4 years.

Regulators are warning surgeons not to implant the devices in combination with each other and encouraging them to conduct annual follow-ups with all patients who received the implants for the life of the implant, to test for rising metal ion levels in their blood.

In New Zealand, Stryker is asking surgeons to contact 41 patients there who received the implant, according to a report in the Australian News.

In August 2010, DePuy recalled both the ASR resurfacing implant and its related ASR cup due to a high rate of revision surgeries required to correct or remove the defective implants. The pair of implants were used on about 93,000 patients worldwide.

Warsaw, Ind.-based DePuy Ortho snapped up Finsbury in 2009 for $95 million. Stryker Orthopedics distributed the systems in the U.K from 2006-2011.

ITGI surges on cranial stent CE Mark

Spacelabs Healthcare wins 510(k) for Qube monitoring system

FDA gives Chromogenex clearance for i-Lipo fat laser

Custom Spine wins 510(k) for cannulated screw system

Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
Medtronic execs see quick recovery, increased M&A
If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]
Goddard teams with Swab56 on COVID-19 test swabs
Mechanical engineering and industrial design company Goddard announced that it is working with the Swab56 Project to rapidly increase the production of Swab56’s test swabs, which are used in healthcare facilities to test for COVID-19. As news reports have documented, traditional nasopharyngeal swabs are in short supply as healthcare facilities around the world struggle to keep… […]
This patient-mover got an emergency COVID-19 nod from the FDA
AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic. “PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases… […]
Sommetrics lands ISO 13485 certification
Sleep apnea treatment device startup Sommetrics announced yesterday that its quality management system has been certified to the ISO 13485:2016 standard. During the audit process required for certification, Sommetrics was also evaluated and found to be in compliance with the standards of the Medical Device Single Audit Program (MDSAP) for Canada. “This is an important… […]