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hip device 31 articles

Smith & Nephew recalls 7,700 metal hip devices

In June, medical technology corporation Smith & Nephew announced it is recalling its R3 Acetabular System, an optional metal liner component usually used in conjunction with stemmed total hip implants. This latest recall adds to growing fears over the high rate of premature failure associated with artificial hip implants made with metal-on-metal components and the speed at which many of these devices were rushed to market. “We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” Andy Weymann MD, Smith & Nephew’s Chief Medical Officer said in a statement about the ... Read More

New study sheds light on “genotoxic” damage rendered by metal hip implants

Researchers have a better understanding of why patients often suffer from inflammation and other long-term, chronic illnesses after being implanted with artificial hip devices made from all metal parts, such as the ASR hip implants recalled by DePuy Orthopaedics in August 2010. Researchers from Ohio State University and Imperial College London have combined high-resolution X-ray technology and electron microscopy to study the inflamed tissue surrounding the metal-on-metal hip devices implanted in patients. Their study, published in the journal Chemical Communications, found that inflammation occurs when Cobalt2+ ions are shed by the cobalt-chromium implants into the surrounding tissue. Previous studies have ... Read More

Canada issues new alert for metal hip patients and their doctors

Canadian regulators have issued a new alert for patients who have been implanted with metal-on-metal hip devices, advising them to watch for certain signs that could indicate the implants are failing. Prompted by growing concerns over the safety of hip implant devices made of all-metal components, Health Canada says that patients who have received such implants should “be on the lookout for pain the groin, hip or leg, swelling at or near the hip joint, or onset of a limp or change in walking ability or limited range of motion,” according to The Canadian Press. Much of the concern about ... Read More

UK regulators issue warning about DePuy’s MITCH TRH all-metal hip implants

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety warning for MITCH TRH acetabular cups and MITCH TRH modular heads – a metal-on-metal hip implant system manufactured by U.K.-based Finsbury Orthopaedics, a division of DePuy Orthopaedics. Both companies are owned by healthcare giant Johnson & Johnson. The MITCH TRH System is a metal-on-metal hip replacement system consisting of components that can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. In the new Medical Device Alert, MHRA regulators warn that a higher-than-expected number of DePUY MITCH hip devices ... Read More

Some DePuy ASR hip implant lawsuits heading to trial this year

The first lawsuits filed against health care giant Johnson & Johnson and its subsidiary DePuy Orthopaedics by plaintiffs alleging injuries caused by DePuy’s metal-on-metal ASR hip devices will go to court this year. About 4,200 lawsuits have been filed against the companies in federal court, with another 2,000 filed in state courts. The first state lawsuits are slated to go to trial in Las Vegas, Nevada, in mid-December 2012, with another trial scheduled for January 2012 in a Maryland state court. Federal lawsuits, which will be tried in U.S. District Court in West Virginia, will probably be heard in March ... Read More

FDA plans 2-day metal hip device review

Responding to growing concerns over complications associated with metal-on-metal hip implant devices, the U.S. Food and Drug Administration (FDA) said it has planned a two-day review of the devices in June that could result in tougher regulations. A global recall of two different all-metal hip implants made by DePuy Orthopaedics in 2010 compounded fears that such devices could fail prematurely and harm recipients, sometimes in serious, debilitating ways. A number of other companies manufacture metal-on-metal hip implants, but most complaints center around DePuy’s ASR XL Acetabular and Hip Resurfacing systems. “We are asking outside scientific and medical experts to discuss ... Read More

FDA to scrutinize metal-on-metal hips in June

Signaling more trouble for metal-on-metal hip devices and their manufacturers, the U.S. Food & Drug Administration (FDA) announced it has planned a 2-day review of the controversial medical devices, which have become the subject of thousands of personal injury lawsuits around the world. “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health, said in a statement. Hip replacement systems made with all metal components were first conceived about ... Read More

Metal-on-metal hip implants suspected as source of pain for another patient

Patients needing hip replacement surgery should do their homework and avoid implants made with metal-on-metal parts, warns Tracie Ephgrave of the UK. “I just don’t want people to go through what I have,” she told the Gazette News.  In 2001, Tracie had a hip implant to help ease the pain and limited mobility she suffered from a form of arthritis she had as a child. She received a metal-on-metal implant designed to be more durable than traditional, ceramic models. But two years after receiving the implant, she heard a clunking in her hip joint. Soon after, her pain returned – with ... Read More

British registry shows DePuy hip implants failure rate rising

An estimated one-fifth to one-third of patients who have received a metal-on-metal hip replacement system made by Johnson & Johnson subsidiary DePuy Orthopaedics have had the devices fail them, according to the National Joint Registry for England and Wales. The report suggests the problem with the artificial hips is even greater than first expected. The United States does not have an established registry for replacement joints, but reports to the Food and Drug Administration (FDA) have also indicated the DePuy artificial hips were failing at a higher than expected rate. The hip implants were recalled last fall, affecting an estimated ... Read More

DePuy names new president following artificial hip recall

Johnson & Johnson subsidiary DePuy Orthopaedics has named Andrew Ekdahl as its new president. Ekdahl replaces David Floyd, who resigned in March about six months after the company issued a massive recall of the its metal-on-metal artificial hip device. Floyd had served as president of DePuy for four years. Ekdahl is a 20-year veteran of DePuy’s othopaedics, trauma, spots medicine, neurosciences and spin units and was the franchise vice president for DePuy Europe, Middle East and Africa. As president, Ekdahl faces an uphill challenge with the recall of its hip implant. The recall affects about 93,000 people worldwide. The recall ... Read More