J&J unit DePuy issues global recall of 93,000 hip replacement systems
27 August 2010
Johnson and Johnson (J&J) unit DePuy Orthopaedics, Inc yesterday issued a global recall of two hip replacement products after finding that more people than expected who underwent hip replacement surgeries experienced pain and other symptoms that led to a second hip replacement surgery.
The recall comes just two days after DePuy was warned by the US Food and Drug Administration (FDA) for illegally marketing two other products without its approval and another unit of J&J issued a global recall of millions of its 1 Day Acuvue contact lenses on manufacturing problems that causes eye to prickle. (See: J&J issues global recall for 1 Day Acuvue contact lenses)
DePuy said that it is recalling two hip replacement products because data recently received by the company showed that more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery.
According to the company, five years after implantation, approximately 12 per cent of patients or 1 in 8 who had received the ASR resurfacing device and 13 per cent of patients or 1 in 8 who had received the ASR total hip replacement needed to have a revision surgery.
DePuy, based in Warsaw, Indiana is recalling its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System.
The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis, while the ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur.
DePuy said that the recall would mean additional testing and treatment may be necessary to ensure the hip is functioning well and warned that in some cases, patients may need additional surgery.
DePuy said that it intends to cover "reasonable and customary costs of monitoring and treatment for services," including additional surgery costs associated with the recall of its ASR systems.
J&J is operating under continuous scrutiny by the FDA, Congress and federal prosecutors over eight recalls of non-prescription medicine this year that includes Tylenol, Benadryl, Motrin and Zyrtec, and other pain relievers. (See: Johnson & Johnson recalls 43 children's drugs)