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ASR hip replacement system 41 articles

Australian man says DePuy knew hip implants were faulty, failed to take action

Like more than 90,000 other people around the world, Howard Brown, a resident of Sandgate in Queensland, Australia put his trust in DePuy Orthopaedics and received one of their all-metal hip implants in July 2008. The 67-year-old retiree looked forward to a better quality of life the supposedly durable implants offered, but shortly after surgery his health took a turn for the worst. Mr. Brown told Australia’s Newcastle Herald that about a year ago his health took a turn for the worst, starting with burning sensations in his leg that he said would “virtually bring tears to my eyes.” Particles ... Read More

U.K. registry finds increasingly higher failure rate for DePuy ASR hip implants

The National Joint Registry for England and Wales (NJR), the largest registry in the world to track orthopedic devices, has reported more bad news about metal-on-metal hip implants. The latest NJR report, released last week, spells trouble for recipients of many kinds of all-metal hips, but is especially ominous for patients who received one of the two DePuy ASR hip implants that the manufacturer recalled last August. According to the new report, metal-on-metal hip implants, which were intended to be more durable and longer lasting than traditional metal and plastic implants, are failing at increasingly higher rates. Failure rates are ... Read More

FDA launches new training program for medical device reviewers

The Food and Drug Administration (FDA) has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH). This program is just one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process, an expedited approval process granted to moderate-risk medical devices determined to be “sufficiently similar” ... Read More

Metal-on-metal hip implants could be biggest medical problem in years

The number of complaints about metal-on-metal hip implants has skyrocketed since the Food and Drug Administration (FDA) opened an investigation into the safety of the devices, confirming fears that the artificial hips may become the biggest and most costly implant problem the medical industry has seen in years. More than 5,000 reports of problems with metal-on-metal hip implants have been reported to the FDA since January – more than the previous four years combined, according an analysis by the New York Times. Metal-on-metal hip replacement systems were marketed as a stronger, more durable device than the traditional ceramic ones previously approved ... Read More

San Diego man sues DePuy, alleging hip implant poisoned him

A San Diego man who underwent revision surgery to replace the DePuy hip implant he originally received described the experience to San Diego’s 10News as “a nightmare.” The 62-year-old man said he also feels angry because he feels DePuy rushed the medical device to market without adequately testing it for safety. He is now joining dozens of other San Diego-area residents who seek damages from DePuy for the pain, illness, and other hardships they allege their DePuy hip implants caused. DePuy Orthopaedics recalled its ASR hip devices a year ago after clinical trials found a high rate of failure for ... Read More

Medical device companies seek to discredit IOM on device approval process

Medical device companies are waging a campaign to discredit the recommendations of the Institute of Medicine (IOM) that include doing away with the Food and Drug Administration (FDA) accelerated approval process for moderate-risk medical devices. IOM is an independent, nonprofit institute that provides information and advice on issues concerning health and sciences. The FDA asked the institute more than two years ago to make recommendations on improving its 510(k) process, which is designed to get moderate-risk devices on the market faster. The process also greatly cuts down on the time it takes for medical device companies to begin selling and ... Read More

IOM recommends overhaul of FDA’s expedited medical device approval process

Moderate-risk medical devices such as artificial hips should be reliably screened by the Food and Drug Administration (FDA) for safety and effectiveness before those devices are marketed to doctors and patients, according to a new report by the Institute of Medicine (IOM). The FDA currently approves these Class II devices under at 35-year-old process known as 510(k). This process was designed to get devices on the market faster. It can be used when new devices are determined to be sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975, when the 510(k) ... Read More

IOM to make recommendations on FDA medical device approval process

The Institute of Medicine (IOM) this week is expected to offer advice on the Food and Drug Administration’s fast-track process by which medical devices are approved for use in patients in hopes of cutting down on injuries and recalls. The accelerated approval process, known as 510(k) is widely used by the agency to get much-needed medical devices on the market. It is allowed on devices that are considered “substantially equivalent” to existing products. About 3,000 products are approved by the FDA through this process each year. Critics say this accelerated approval process puts medical devices on the market before they ... Read More

Patients with metal artificial hips may have case against manufacturer

About a thousand lawsuits have been filed against Johnson & Johnson subsidiary DePuy Orthopaedics over its defective ASR hip replacement system, which caused patients pain, disability and additional surgeries. However, the company refuses to compensate patients for anything more than their medical expenses. Soon after the DePuy metal-on-metal artificial hip hit the market in 2006, reports of premature failures began to pour in. The devices were loosening, dislocating and fracturing. Patients were also testing positive for metallosis, a blood poisoning caused by bits of metal from the device leaching into the bloodstream. By fall of 2010, DePuy had little choice ... Read More

Texas teacher sues DePuy over harm caused by hip implant

A retired Texas school teacher and counselor has filed a personal-injury lawsuit against DePuy Orthopaedics and its parent company Johnson & Johnson, seeking compensation for debilitating injuries allegedly caused by her DePuy ASR hip implant. This newest lawsuit was filed in the United States District Court for the Northern District of Ohio, Western District, where Judge David Katz is presiding over multi-district litigation (MDL) involving DePuy’s recalled hip implants. The 67-year-old plaintiff underwent surgery in January 2009 to have a DePuy ASR XL Acetabular hip system implanted in her right hip. However, instead of improving her mobility and quality of ... Read More