DePuy Hip Replacement Injury Lawyers
In 2005, the DePuy ASR XL Acetabular System, a metal on metal (“MOM”) hip replacement, was cleared by the FDA. DePuy, a subsidiary of Johnson & Johnson, received special clearance to market their MOM hip replacement products through the agency’s 510(k) process. To read more about the process a device goes through to get approved, click here.
MOM hip implants, where both the artificial ball and cup are made of metal, account for nearly one-third of the estimated 250,000 replacements performed each year. In August 2010, DePuy voluntarily recalled its ASR product line. This recall came after data indicated that the 5 year failure rate of DePuy’s hip replacement product was approximately 13%, or 1 in 8 patients (typically, hip replacements last 15 years). Unfortunately, 93,000 persons worldwide received an ASR implant (approximately 40,000 in the US), meaning a great number of people are likely affected. The recall means that patients who have already undergone one surgical procedure to replace a hip will have to undergo a second surgery to replace the defective device. But even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments and tiny particles of cobalt and chromium that might not be discovered for years.
The FDA has received more than 5,000 complaints about MOM implants since January 2011. In May 2011 the FDA ordered manufacturers to study how frequently the devices were failing and to examine the threat to patients.
Problems with the device occur as a result of the product wearing down or components loosening or becoming misaligned. Possible side effects include infection, bone fractures, bone staining, necrosis, swelling, dislocation, nerve damage, tissue damage, muscle damage, metal sensitivity, increased metal ion levels in the blood and pain.
The first lawsuit against DePuy was filed in June 2010. The patients’ complaints range from the fear of future complications for those whose device has been recalled but have no symptoms, device failure, or elevated heavy metal in their system to those whose devices have been removed, those who are suffering from increased metals in the blood and those who are in extreme pain due to mass formation, bone loss and tissue necrosis.
If you or a loved one is concerned about a hip replacement device or is experiencing any side effects from a hip replacement, please contact Cohen & Malad, LLP to speak with one of our experienced product liability/personal injury attorneys to discuss your legal options and help you seek the compensation you deserve.