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metal-on-metal hips

Feds want more input on materials with ‘high-profile safety concerns’

May 20, 2021 By Nancy Crotti

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 […]

Filed Under: Food & Drug Administration (FDA), Gynecological, Implants, Metal-on-Metal, Women's Health Tagged With: breast implants, Essure, FDA, metal-on-metal hips

Zimmer Biomet wants federal court to throw out $3.55M hip implant judgment

February 17, 2021 By Chris Newmarker

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 […]

Filed Under: Featured, Legal News, Metal-on-Metal, News Well, Orthopedics, Product Liability Tagged With: metal-on-metal hips, Zimmer Biomet

Report: Johnson & Johnson to settle metal-on-metal hip cases for $1B

May 7, 2019 By Brad Perriello

Most of the remaining metal-on-metal hip cases facing Johnson & Johnson (NYSE:JNJ) subsidiary DePuy could reportedly be settled for about $1 billion. The deal, which includes a prior $400 million settlement, covers about 95% of the 6,000 cases involving Pinnacle hip implants that had to be removed, Bloomberg reported, citing two “people with knowledge of […]

Filed Under: Featured, Implants, Legal News, Orthopedics, Wall Street Beat Tagged With: Ethicon, Johnson and Johnson, metal-on-metal hips

The grim stories behind seven of medtech’s worst failures

April 19, 2019 By Danielle Kirsh

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Diagnostics, Food & Drug Administration (FDA), Implants, Metal-on-Metal, Regulatory/Compliance Tagged With: Bayer, birth control, duodenoscope, Essure, MedTech, Medtronic, metal-on-metal hips, pacemakers, Theranos

FDA ramps up scrutiny of materials in medical devices

March 15, 2019 By Nancy Crotti

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 […]

Filed Under: 510(k), Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, Materials Testing, Metal-on-Metal, News Well, Oncology, Orthopedics, Regulatory/Compliance, Replacement Heart Valves, Stents, Surgical, Women's Health Tagged With: animalmaterials, Bayer, Breast Cancer, breast implants, FDA, internationalconsortiumofinvestigativejournalists, metal-on-metal hips, Netflix, nitinol

FDA chimes in on off-label use, preemption in Smith & Nephew hip suit

September 21, 2017 By Brad Perriello

The FDA last week chimed in on a lawsuit brought against Smith & Nephew (NYSE:SNN) by a patient whose surgeon used the company’s hip implants off label, arguing that federal law preempts most tort claims even when medical devices are used outside of their indications. Plaintiff Walter Shuker was implanted with components from Smith & Nephew’s […]

Filed Under: Food & Drug Administration (FDA), Legal News, Product Liability Tagged With: metal-on-metal hips, Smith & Nephew

Plaintiff wins new trial in DePuy ASR XL hip suit

September 21, 2017 By Brad Perriello

The plaintiff in a product liability lawsuit brought against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes won a new trial after an Illinois state court found that a joint replacement researcher’s testimony was unfairly excluded from her original trial. Carol Strum lost her first trial in April 2013 after a Chicago jury rejected her claims that the company, […]

Filed Under: Legal News, Orthopedics, Wall Street Beat Tagged With: depuysynthes, Johnson and Johnson, metal-on-metal hips

Failure to thrive: Lessons learned from medtech innovations that missed the mark

March 17, 2017 By Chris Newmarker

Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes. Fink Densford, Associate Editor No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut. […]

Filed Under: Business/Financial News, Diagnostics, Food & Drug Administration (FDA), Metal-on-Metal, Orthopedics, Recalls, Research & Development Tagged With: Johnson and Johnson, Kablooe Design, Medgineering, MedTech, metal-on-metal hips, Sedasys, Theranos, vascularsolutions

Stryker Q4 earnings take hit from recalled hip implants

January 24, 2017 By Chris Newmarker

Stryker’s profits decreased 2.3% year-over-year in the fourth quarter, to $510 million, amid charges related to its recalled Rejuvenate or ABG II modular metal-on-metal neck hip stems, as well as expenses related to restructuring and acquisition costs. Earnings per share were $1.34, down 2.9% year-over-year, the company reported Tuesday evening. Excluding the charges, Stryker’s profits would […]

Filed Under: Business/Financial News, Metal-on-Metal, News Well, Orthopedics Tagged With: MedTech, metal-on-metal hips, Stryker

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