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Wright Medical 22 articles

Wright Medical and MicroPort Orthopedics Accused of Hiding Defect in Hip Implant

Two cases filed against Wright Medical Technology Inc. and MiroPort Orthopaedics Inc. have been consolidated by a California federal judge. The lawsuit accuses the companies of hiding a crucial defect in their metal cup-and-ball hip implants. The two plaintiffs allege the Profemur Total Hip System broke “suddenly and catastrophically,” leading to emergency surgery that requires damaging the femur. In one case the Profemur implant lasted only 37 months, the other a mere 20 months. The lawsuit comes in the midst of Wright Medical’s multidistrict litigation (MDL) battle against claims that its Conserve Hip Implant, a metal-on-metal hip implant system, has been releasing metal ions into ... Read More

European Medical Device Regulations Tightened Due to Metal-on-Metal Hip Implant Safety Concerns

New medical device regulations (MDR) have been put in place by European Parliament after four years of negotiation. The decision to tighten regulation was spurred by safety concerns over breast implants and metal-on-metal hips. The regulation amendments are expected to begin in early 2017, and medtechs will be allowed three years to comply. If the medical products fail to meet the new regulation standards, the manufacturer will lose their CE rating, which allows legal marketing of the product. The new regulations include stricter rules regarding clinical trials, quality management, and marketing necessities such as product labeling and design. Regulators will now inspect Class ... Read More

Large-Diameter Metal-on-Metal Hips Sparked Study on Metal Allergy

A Missouri orthopedic surgeon and colleagues have initiated a study that identifies the patients who underwent total joint replacement reporting a metal allergy. The study analyzes the effect of voluntary reported metal allergies on the clinical outcomes following the surgery. Dr. Denis Nam, recipient of the Orthopaedic Research and Education/Current Concepts of Joint Replacement (CCJR) Clinical Award Paper, along with other researchers, gathered retrospective data from 589 patients who received total knee arthroplasty (TKA), and 906 patients who received total hip arthroplasty between the years of 2009 and 2011. Before January 2010, the incidence of self-reported metal allergy was 1.7 percent. After January 2010, the incidence was 4 percent. ... Read More

Wright Medical Agrees to $240 Million Settlement Over Metal-on-Metal Hip Injury Claims

Wright Medical Group, a medical device manufacturing company based in Amsterdam, Netherlands, has entered into a settlement over litigation involving its metal-on-metal hip implants. The litigation included 1,292 claims that the company’s Conserve, Dynasty or Lineage hip implants resulted in revision surgeries. Wright also estimates that about 600 cases won’t be included in the settlement, and has stated that it will “vigorously defend” those that weren’t settled. The settlement is for an eye-popping $240 million – $60 million going to insurance recoveries, and $180 million to be paid in cash. Robert Palmisano, Wright’s own CEO, said he was glad to reach the settlement so that the company ... Read More

Cobalt Toxicity is a Serious Risk for Metal-on-Metal Hip Patients

When Robert Peters wrote the Daily Mail for advice from Dr. Scurr about concerns with his metal-on-metal hip implants, the response seemed to only confirm his greatest fears – that his hip implants could be poisoning him. Peters’ blood was tested after his surgeon informed him of the recent reports of metal-on-metal hip failures. “Blood tests revealed I have 100 times more than normal the amount of cobalt in my blood,” Peters wrote, “as well as dangerous amounts of chromium.” Dr. Scurr explained that metal-on-metal hips are usually made of a stainless steel alloy containing cobalt and chromium, and were intended to ... Read More

The U.S. Department of Health and Human Services Adds Cobalt to List of Carcinogens

On Nov. 3, 2016 The U.S. Department of Health and Human Services (HHS) released the 14th Report on Carcinogens (RoC) that includes cobalt and cobalt compounds on its list of cancer-causing substances. The RoC is a public health document that is science-based and congressionally mandated, describing 248 listings of agents, substances, mixtures, and exposure circumstances that are known and confirmed carcinogens. The report advises that “intracellular release of cobalt ions from particles” is a key event related to toxicity and carcinogenicity, as seen the cases of metal-on-metal hip implant failure. Metal-on-metal hip implants are made primarily of cobalt and chromium alloy. Patients who have received this ... Read More

Metal Poisoning from Metal-on-Metal Hips Linked to Skin Rashes and Cardiomyopathy

Metal-on-metal hips are primarily made of cobalt and chromium. When these components rub together with normal use, the parts wear down and corrode, causing metal to leach into the surrounding tissues and bloodstream. Once in the bloodstream, the metal content can cause metal poisoning called metallosis. Side effects may include implant failure, necrosis (tissue and bone death), and organ damage. These side effects may require revision surgery to treat. Pseudo tumors are also a side effect of the metal poisoning. The tumors are soft tissue changes in the surrounding tissues and bone of the hip prosthetic. According to a study published June 2015, ... Read More

Scottish Man’s Metal Hip Removed After Only Three Years leaving him Permanently Crippled

John Haldane was 68 when he received a new hip, a metal-on-metal design that he was told would last two decades. Three years later, the hip had to be removed, leaving him permanently crippled. “I’m disabled and this should not have happened,” Haldane said. “I just want the company which made the implants to take responsibility.” Now, 88 people who allege they were permanently injured by metal-on-metal hip implants are seeking compensation for the agony and problems they say they experienced from their new prosthetic. Their ages range from 30s to 80s, and each claim their lives have been ruined by the faulty device. They’re ... Read More

Patients with Metal-on-Metal Hip Implants Need Lifelong Blood Checks

Metal-on-metal hip implants have been a health concern ever since patients began coming forward with reports of complications from their new hips. In an article published by BBC News, patients who have received a metal-on-metal hip implant need lifelong blood checks for cobalt and chromium levels. Manufacturers of metal-on-metal hip implants, such as DePuy Orthopaedics, a subsidiary of Johnson & Johnson,  Smith & Nephew, Wright Medical, Zimmer Biomet Holdings and Stryker are facing lawsuits alleging the devices resulted in problems including loosening, bone erosion, damage to surrounding tissue as well as metallosis, a dangerous blood condition that occurs when metal bits flake off the device and make their way into the bloodstream. The metal-on-metal ... Read More

Wright Medical Pushing Eleventh Circuit for a Retrial in metal-on-metal hip implant litigation

Wright Medical, one of the manufacturers of metal-on-metal hip implants, is pushing the Eleventh Circuit for a retrial in the first bellwether case of the multidistrict litigation (MDL) that alleges the devices are faulty and lead to permanent injury. Robyn Christiansen was the recipient of a metal-on-metal Wright Conserve Hip Implant System that the jury deemed defective. Christiansen was awarded $1 million in compensatory damages last April, and $10 million in punitive damages. Although U.S. District Judge William S. Duffey, Jr., gave the company credit for its intentions to improve the quality of life for active patients looking for a lasting hip system when so ... Read More