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revision surgery 140 articles

DePuy continued to make and sell faulty metal hip implants for months before recall

DePuy Orthopedics and its parent company Johnson & Johnson knew in 2008 its ASR metal hip implants were failing early at unusually high rates, but they continued to make the devices for several more months before finally recalling them in August 2010, newly released court documents show. The findings were contained in a number of pretrial depositions and internal company records unsealed before the scheduled start of the first trial over DePuy’s faulty implants on Friday. The case, which will be tried in California Superior Court in Los Angeles under Judge J. Stephen Czuleger. The trial will likely reveal a ... Read More

Court documents show DePuy knew nearly 40 percent of its hip implants failed within 5 years

Documents unsealed ahead of the first faulty hip implant lawsuit against Johnson & Johnson and DePuy Orthopedics to go to trial show that company executives knew in 2011 that its ASR metal hip implants would fail in nearly 40 percent of patients within five years, but withheld that information. DePuy, a division of medical giant Johnson & Johnson, recalled its ASR XL Acetabular and ASR Hip Resurfacing Systems in August 2010 as evidence mounted that the hip devices, which consisted of a metal ball and metal cup, failed at unusually high rates. At the time of the recall, the devices ... Read More

FDA proposes new rules for metal-on-metal hip implant approval

The U.S. Food and Drug Administration (FDA) has proposed new regulatory rules that, if passed, will require orthopedic device manufacturers to test their all-metal hip replacement and resurfacing systems for safety and efficacy before approval. The proposed measures come in response to alarmingly high rates of failure and injury associated with metal-on-metal hip devices, such as the ASR XL Acetabular and Hip Resurfacing Systems made by DePuy Orthopedics, which were recalled for safety concerns in August 2010 after being implanted in about 93,000 patients worldwide, including approximately 40,000 Americans. The FDA’s proposed order would require manufacturers to file a premarket ... Read More

Companies should avoid covering up issues related to product recalls

When companies are required to recall their products due to problems or reports of injury, the worst thing they can do is try to cover up the mistake, says Kevin Erb, a public relations and social media director. “It’s not the crime, it’s the cover-up,” that can tarnish a company’s public image, Erb told the Journal Gazette. Thus, companies should be prepared for product issues and recalls to arise and have a plan in place. Doing so, Erb said, sets the tone for media coverage and public reaction. Erb’s sage advice should be noted by pharmaceutical companies and medical device ... Read More

New study underscores dangers posed by metal-on-metal hip implants

Just over a decade ago, when orthopedic device manufacturers began making hip implants with all metal parts, some researchers warned that the metal-on-metal designs could pose a health threat. They knew that all artificial hip implants, whether made of ceramic, plastic, metal, or a combination of materials, shed particles into the blood and tissue through normal wear and tear. But, according to a New York Times report, “those warnings were not heeded, and now doctors and patients face a growing public health problem as one of the country’s biggest medical device failures unfolds.” At the same time, there has been ... Read More

Rochester’s DePuy metal hip lawsuit will serve as example for other lawsuits

A lawsuit filed by a Rochester, NY woman against the manufacturer of an all-metal hip replacement system will serve as the example for more than 7,000 similar lawsuits across the country. Ann McCracken filed a lawsuit against DePuy Orthopaedics and it parent company Johnson & Johnson after her DePuy metal-on-metal artificial hip failed prematurely, requiring her to undergo revision surgery to remove and replace the defective hip implant. Artificial hips are traditionally made with ceramic or plastic parts, but in the past decade manufacturers began making hip implants with all-metal parts. The design turned out to be flawed, resulting in ... Read More

New consortium aims to improve safety of medical devices

The Food and Drug Administration (FDA) has caught much flack in the past couple years over its medical device approval process, with critics arguing that not enough effort is made to ensure the safety and efficacy of devices before they hit the market. In response, a new consortium of leaders from industry, academia and government agencies was formed to help guide the advancement of medical device regulatory science. The Medical Device Innovation Consortium (MDIC), is a public-private partnership with the FDA’s Center for Devices and Radiological Health (CDRH). FDA Commissioner Dr. Margaret Hamburg called the formation of the consortium a ... Read More

International safety alert issued on metal hip device

Medsafe, New Zealand Medicines and Medical Devices Safety Authority, has issued an international safety alert on the Durom Acetabular Cup, an artificial hip device that was discontinued by its manufacturer in June 2011. The device has been failing at a higher than expected rate, causing some patients to undergo revision surgery to have their defective hip implants removed and replaced. The Durom Acetabular Cup, made by Zimmer Inc., is designed with metal-on-metal parts, just like the DePuy Orthopaedics ASR XL Acetabular hip replacement system and resurfacing system. The Depuy device was recalled by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, ... Read More

First hip-injury lawsuit against DePuy gets green light in Ireland

An Irish woman who had both of her hips replaced with DePuy hip implants filed what is expected to be the first of many lawsuits against the orthopedic device maker in Ireland. Irene Pierson alleges in her lawsuit that the DePuy hip implants were “not of merchantable quality, and have both commenced to malfunction,” Ireland’s Kildare Nationalist reported. Ms. Pierson had her right hip replaced with a DePuy implant in March 2007. She was fitted with a DePuy implant in her left hip in September 2008. Ireland’s High Court granted Ms. Pierson approval to serve the defendants she names in ... Read More

Man files lawsuit against makers of recalled metal hip implant

“It started to feel a bit clunky and was grinding and then it started to squeak very loudly – loud enough for people in the street to be startled and stare at me,” Chris Monk told the Evening News of his artificial hip. “I was in so much pain and could barely walk a few yards when it was at its worst.” Monk had scans that showed his all-metal hip implant was defective and had damaged his flesh. It had also dropped bits of metal debris inside his body that seeped into his bloodstream causing a type of blood poisoning ... Read More