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hip implant 241 articles

FDA provides guidance to help medical device manufacturers gain faster marketing approval

The Food and Drug Administration (FDA) is providing manufacturers with information to help them win faster approval for medical devices deemed “substantially equivalent” to other devices, even if the technology of the new device is different or carries different risks. The guidance is designed to prevent defective medical devices from passing through the agency’s abbreviated 510(k) approval process, which allows faster clearance to moderate risk devices if they are similar to other devices currently on the market. The FDA has been revamping the 510(k) process since it was revealed four years ago that the faulty Johnson & Johnson DePuy ASR ... Read More

Johnson and Johnson to pay Oregon $4 million for deceptively marketing metal hip implants

Johnson & Johnson will pay $4 million to settle a lawsuit with the State of Oregon over claims that the company failed to warn doctors and patients that its artificial hip had a high failure rate. The settlement is being called the first of its kind by the Oregon Department of Justice. The settlement involves Johnson & Johnson’s subsidiary DePuy Orthopaedics’ ASR metal-on-metal hip replacement system, which was recalled in 2010 after mounting reports of premature failure. Not only were the devices failing at a higher than expected rate, in some cases the metal devices were corroding inside the body, ... Read More

Metal hip manufacturer faces new lawsuits alleging defective design

At least five new lawsuits were filed against Stryker Corp., and its subsidiary Howmedica Osteonics Corp., claiming that the companies’ hip implant was defective, causing injuries and poisoning blood. The lawsuits involve the Accolade TMZF hip stem and LFIT anatomic V40 femoral head. Stryker already is facing more than 500 similar lawsuits over other artificial hip models, the Rejuvenate and ABG II modular-neck stems. According to the complaint, the titanium hip stem can corrode when it is used with the femoral heads, which are made from cobalt and chromium. When the metal corrodes inside the body, it can inflame tissue, ... Read More

Family says defective metal-on-metal hip implant caused mother’s brain cancer

A woman who had filed a lawsuit against Johnson & Johnson for its defective metal-on-metal hip implant has died of an aggressive brain cancer, a disease her family believes was caused by blood poisoning from her corroding artificial hip. Bharucha had broken a hip when she suffered a fall and in 2007 was fitted with Johnson & Johnson’s DePuy ASR hip replacement system. The surgery did not relieve her pain or help her regain her mobility. In fact, she grew increasingly worse. By 2011, a year after the device was recalled due to premature failures, Bharucha had revision surgery to ... Read More

Consumer Reports group pushes for warranties on artificial hips

Nearly a half-million Americans each year undergo hip replacement surgery, an invasive operation that requires weeks of rehabilitation. Typical hip implants can last 20 years or more before being replaced, but some have been shown to fail at a faster than expected rate. Thus, the Safe Patient Project, organized by Consumer Reports, is pushing for all hip implants to come with warranties. “One, it tells people how long this implant’s going to last,” said Lisa McGiffert of the Safe Patient Project. “It gives them realistic expectations. And two, it gives them a clear process to follow if their implant should ... Read More

More government oversight credited for jump in medical device recalls

The number of medical device recalls has doubled in the past 10 years, according to a new report, a result of more government oversight and manufacturers doing a better job of halting sales of defective devices, officials say. Yearly recalls jumped from about 600 in 2003 to 1,200 in 2012, according to the report, which was prompted in 2011 by the Government Accountability Office (GAO). The largest rise was due to radiological devices, such as MRI and CT scanners, which have been found to register false positives and increase the risk of cancer. A fifth of the recalls in 2012 ... Read More

Increasing number of people in U.S. getting hip replacement surgery

An estimated 7 million people in the United States – or 2 out of every 100 – have had a total knee or hip replacement, according to a Mayo Clinic study. The research was the first major study to estimate how common joint replacement has become in the United States. Dr. Daniel J. Berry, chairman of orthopedic surgery at the Mayo Clinic and author of the study, reviewed federal databases on surgeries and life expectancy trends and reported those findings this month at the American Academy of Orthopaedic Surgeons conference in New Orleans. Until now, since the United States didn’t ... Read More

Researchers find metal ion concentration, device brand may predict hip implant failure

The amount of metal ions in the blood and the type of hip implant may predict premature failure of metal-on-metal hip replacements, according to a team of United Kingdom researchers. Researchers reviewed data from 299 resurfacing procedures in 278 patients with various brands of hip implants. The patients had reported complications that were likely related to high levels of metal in their blood. Patients were put through a blood metal ion screening protocol, ultrasound scanning, and joint aspiration to determine the level of cobalt concentration. Researchers found that blood-cobalt concentration and the type of device used were significant risk factors ... Read More

Biomet to pay $56 million to settle metal-on-metal hip implant lawsuits

Medical device company Biomet Inc. has agreed to pay at least $56 million to settle multidistrict litigation (MDL) in Indiana federal court claiming its metal-on-metal hip replacement devices were defective. MDLs are special federal legal procedures designed to speed up the process of handling complex cases, such as product liability lawsuits. Biomet disputes the fact that its devices caused people harm, however it agreed to set aside the money for MDL plaintiffs who qualify. The agreement resolves the MDL, which it has been fighting since October 2012. Plaintiffs in the MDL who received either the Biomet M2a-38 or M2a-Magnum hip ... Read More

3 medical devices that can harm you

Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good: 1. Transvaginal mesh – Also known as vaginal ... Read More