The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
Metal-on-Metal
FDA warns of biocompatibility concerns with NuVasive’s Precise devices
The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA). Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a […]
Feds want more input on materials with ‘high-profile safety concerns’
The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]
Zimmer Biomet wants federal court to throw out $3.55M hip implant judgment
Zimmer Biomet (NYSE:ZBH) wants either a judgment or a new trial after a federal jury’s $3.55 million award in a metal-on-metal hip implant case. The jury awarded the money to Lori Nicholson and her husband Willis in November for injuries sustained as a result of the M2A Magnum. In a brief filed Feb. 12, Zimmer Biomet claimed […]
BREAKING: Zimmer Biomet to spin off spine and dental businesses
Zimmer Biomet (NYSE:ZBH) — one of the world’s largest orthopedic device companies — will be a bit smaller going forward. The Warsaw, Ind.–based company announced today that it will spin off its spine and dental businesses into a new, independent, publicly-traded company called NewCo. Zimmer Biomet plans to complete the transaction by mid-2022. The businesses that […]
CoreLink touts 5,000 ortho implants using 3D printed technology
CoreLink announced that it completed the implantation of more than 5,000 3D printed orthopedic devices using its proprietary Mimetic Metal technology. The St. Louis–based company went over the 5,000-implant threshold in November 2019, just over two years on from the first implantation with the F3D anterior cervical interbody in June 2017. Mimetic Metal is an […]
Report: Appeals court revives hip implant lawsuit against Zimmer-Biomet
A federal appeals court has reinstated a personal-injury lawsuit against Zimmer Biomet (NYSE:ZBH) over a metal-on-metal hip prosthesis implanted in 2011. The Third Circuit Court of Appeals revived the lawsuit that a Pennsylvania U.S. District Court judge dismissed in August 2018 because it missed the statute of limitations, according to an article by Law 360. […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Have government scientists solved the artificial hips corrosion problem?
Argonne National Laboratory researchers tested metal alloys that ortho device companies have used in artificial hips for decades. Materials scientists at the U.S. Department of Energy’s Argonne National Laboratory usually test metal alloys for their ability to contain nuclear waste for millions of years. A couple of years ago, two of them decided […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
