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hip replacement system 117 articles

Johnson and Johnson settles metal hip lawsuit

Robert Ottman was ready for his day in court against consumer health care products giant Johnson & Johnson. Ottman underwent total hip replacement surgery in 2008 during which he was implanted with Johnson & Johnson’s DePuy ASR metal-on-metal artificial hip system. Ottman claims the device caused him so much pain and disability that in 2011 he was forced to undergo invasive revision surgery to remove and replace the defective device. In 2010, Johnson & Johnson pulled the hip implants due to an alarmingly high number of premature failures. Ottman’s lawsuit claims that Johnson & Johnson and its subsidiary DePuy Orthopaedics ... Read More

European Parliament considers stronger medical device oversight to better ensure patient safety

Europen Parliament is considering adopting a proposal that would give European drug and medical device regulators more control over medical devices, and require high-risk devices to undergo an approval process before they reach the market. In both Europe and the United States, most medical devices are cleared swiftly for marketing if they can prove they are similar to products already on the market. This has raised safety concerns in the past in both countries, especially after high-profile recalls and safety advisories including the worldwide recall of Johnson & Johnson’s DePuy Orthopaedic ASR metal-on-metal hip replacement system. The devices were granted ... Read More

Researchers: More studies needed to determine long-term cancer risk with all-metal hip implants

Researchers are recommending long-term studies be done on patients with metal-on-metal hip replacement systems to determine whether corroding implants cause cancer. The recommendation was made following a study in which researchers found no increase in cancer in a seven-year period in people with all-metal hip implants. Traditional hip implants are made with plastic or ceramic parts, but in the past decade many manufacturers of these medical devices began making the devices with all metal parts. The metal hips were thought to be more durable and thus ideal for younger and more active patients. However, they devices were found to fail prematurely ... Read More

FDA launches tracking, monitoring program for high-risk medical devices

The Food and Drug Administration (FDA) is launching a new program that requires manufacturers of medical devices to put codes on their products so that the agency can track the devices, monitor their safety, and issue recalls when problems arise. The codes, known as unique device identifier, or UDI codes, placed on each medical device from defibrillators to artificial joints, will be entered into a public, searchable database. The UDI codes must also be noted in medical device records. The first devices to receive the UDI codes will be higher risk devices, including heart pumps and artificial hips. Many low-risk ... Read More

Cyclist files lawsuit against metal hip implant manufacturer

Mark Stephan was riding his bike with friends when he crashed and fractured two vertebrae. He was told he might never walk again. Yet, four years and a hip replacement later, Stephan defied the odds not only by walking again, but by completing a 3,200-mile cycling trip to raise money for the Rehabilitation Institute of Chicago, where he was treated. The victory was short-lived, however. Last year he received a letter stating that the Stryker Orthopedic hip replacement he received in 2011 was recalled because it was defective. Stryker warned that the faulty all-metal hip implants were at risk of ... Read More

Johnson and Johnson considers $3 billion settlement for defective metal hip implant

Johnson & Johnson is considering shelling out more than $3 billion to settle lawsuits related to a faulty all-metal hip replacement system. The payout is about 50 percent higher than the company proposed in previous discussions, and would resolve as many as 11,500 lawsuits in the United States, at more than $300,000 per case. If accepted, the settlement would be the largest involving artificial hips. The lawsuits allege that the metal-on-metal ASR hip replacement system, made by Johnson & Johnson subsidiary DePuy Orthopaedics, was defectively designed, which caused the devices to fail at a higher than expected rate. Thousands of patients ... Read More

Judge denies metal hip maker’s request to dismiss lawsuit in multidistrict litigation

A lawsuit in a multidistrict litigation (MDL) will move forward against Biomet Inc. over its allegedly defective metal-on-metal hip implant after an Indiana federal judge declined the company’s request for dismissal. Biomet argued that the claim against the company was preempted by federal law because the device was approved for use as part of a clinical investigation to determine safety and efficacy. The lawsuit was filed by Leslie Caccia who claimed he received a defective M2A-Magnum hip replacement system, made by Biomet. The complaint states the device damaged bone and tissue surrounding Caccia’s implant and he required multiple revision surgeries ... Read More

DePuy recalls defective femur bone implant

DePuy Othopaedices, a subsidiary of Johnson & Johnson, is recalling an implant used to replace part or all of the femur bone. The device could fracture when exposed to normal weight loads while walking, which can cause pain, infection, loss of limb, neurovascular injury or the need for revision surgery. Patients heavier than 200 pounds and those who are highly active are at greater risk for fracture. DePuy has notified doctors and hospitals of the defect with the LPS Lower Extremity Dovetail Intercalary component. The medical device company is also providing surgeons with a patient letter template for notifying their ... Read More

Many more revision surgeries occur in patients with all-metal hip implants

Nearly 75 percent of revision surgeries to remove and replace a hip replacement within five years of initial implantation occur in patients who received a metal-on-metal device, according to a Canadian study. Researchers pored through data involving 60,000 hip replacements performed across Canada between 2003 and 2011. They found that the need for revision surgery was greater in patients who had large-diameter modular metal-on-metal implants compared to patients who had more common plastic devices. Traditional hip replacement systems are made with ceramic or plastic parts, and can last 20 years or more before needing to be replaced. In the past ... Read More

Corroding metal on artificial hip caused patient neurological symptoms

When orthopedic surgeon Stephen Tower realized in 2006 that in order to continue his recreational cycling he needed hip replacement surgery, he picked the newest and seemingly most durable hip implant on the market at the time – a metal-on-metal device made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The hip implant was specifically marketed to younger, active patients like Stephen. However, after a year Stephen was having pain in his hip and balance issues that caused him to crash his bike. Within the next year, he began experiencing more problems – ringing in his ears, sleep apnea, ... Read More