Product News and Recalls

FDA recalls DePuy Orthopaedics device

The U.S. Food and Drug Administration has announced the recall of a medical device made by Johnson & Johnson subsidiary DePuy Orthopaedics, Fox News reports.

The device, called the LPS Diaphyseal Sleeve, is used in reconstructive knee surgery and was recalled because of the potential for fractures, according to the report.

DePuy is currently facing legal action for another joint replacement device. Approximately 10,000 plaintiffs have filed lawsuits regarding injuries caused by the company’s ASR hip replacement.

A number of studies have shown that nearly half of the hip implants break down and need replacement within six years, as opposed to the minimum of 15 years that’s an industry standard. The hip replacements also have a tendency to leave toxic metal debris in patients’ bodies.

The hip implants were eventually recalled in 2010. But internal documents released during court cases indicate that the company was aware of the devices’ potential for causing injury years before the recall, yet continued to market them anyway.

The FDA has declared the LPS Diaphyseal Sleeve recall “Class 1,” the most serious kind, issued in situations where there is a “reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”

The agency said a fracture in the sleeve at the joint of it could lead to loss of function or loss of limb, infection, compromised soft tissue or death.

You should consult with a doctor if you have any ongoing symptoms or health concerns from a DePuy hip implant. If you have significant injuries, you should also consult with a DePuy hip lawyer to discuss your legal rights.

See the story here:

http://www.foxnews.com/health/2013/02/22/fda-recalls-jj-orthopedic-device-because-fracture-potential/