In August 2010, the Federal Drug Administration (FDA) posted a letter it sent to a medical device manufacturer regarding the safety of its metal hip implants. The letter informed the medical device manufacturer that the FDA had become aware that it had not obtained marketing approval before releasing its metal-on-metal hip implant device for sale and that the company should stop marketing this device immediately.
The medical device manufacturer, DePuy Orthopaedics, Inc., had not received FDA approval for its TruMatch™ Personalized Solutions System prior to releasing it for sale. Therefore, the FDA was warning the medical device manufacturer that it needed to cease production of this product while it went through the proper channels of obtaining the FDA’s approval.
In addition, while DePuy had been cleared by the FDA to market its Corail® Hip System, which was intended to be used for a total hip arthroplasty. However, DePuy had made several changes to its Corail Hip System that were not approved or tested by the FDA and therefore could not legally be marketed or used.
Also, in August 2010, DePuy began issuing voluntary recalls of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. This hip replacement system consisted of metal-on-metal hip implants, i.e., a metal femoral head and metal actabular component. The August 2010 DePuy hip recall affected more than 30,000 Americans who had been fitted with DePuy’s ASR total hip system.
Metal-on-metal implants have been associated with metallosis, which occurs when the hip components grind together and shed some of the metal particles into the blood stream. While metal-on-metal hip replacements were once considered a major breakthrough in hip replacement surgeries, the long-term side effects have led to a drastic decrease in their use by hip replacement surgeons. In addition, a medical study at Chicago’s Rush University Medical Center found that metal-on-metal hip replacements often require subsequent replacement surgeries.
According to the Nationwide Implant Sample Database, about 40,000 Americans received the metal-on-metal implants between 2005 and 2006. Many of the metal-on-metal patients who received that type of implant chose it because of its supposed durability. Therefore, many of those receiving the metal-on-metal hip implants were younger and more active patients. For more information on whether your hip implant has been affected by the recall, visit DePuy’s ASR hip replacement recall guide.
The DePuy hip implant recall has taken on several forms. Complications include hip revision surgery, bone fracture, hip implant dislocation, metal poisoning and a loosening of the implant. These complications have reportedly arisen in up to 49% of the DePuy ASR hip product implants. Early signs of metallosis may show up in groin, hip and leg swelling pain. The DePuy ASR XL hip failure has been reported to fail more frequently than the company announced when it initiated a DePuy ASR hip recall in 2010.
Many of the affected recipients of the DePuy hip products have brought lawsuits in both state and federal courts across the country and Illinois. Contact Kreisman Law Offices for a free consult regarding your DePuy hip replacement case. Chicago’s Kreisman Law Offices has been handling Illinois medical device malpractice lawsuits in and around Cook County for over 35 years, including the areas of Naperville, Schaumburg, Chicago Heights, and Evanston.
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