The New York Times has reported that a Johnson & Johnson/DePuy hip implant that was sold overseas, was rejected by the FDA in 2009.
The implant was new hip resurfacing implant. Unlike traditional hip implants, in which the ball portion of thigh bone or femur is removed and a replacement stem and ball are implanted, this particular implant left the femur largely intact and placed a ball shaped cap over the existing femoral head. Most importantly for U.S. medical consumers, the same pelvic (or ace tabular) cup portion of the implants, was used in both the ASR resurfacing system and the ASR system which was approved and sold in the U.S. That ASR implant was eventually the subject of a recall in August 2010–a full year after the FDA had rejected the sister-product.
Both systems are so-called metal-on-metal hip implants because they involve a metal ball and a metal socket. The apparent problem with the implants is that the design of the metal sockets are such that the friction between the two components creates metal debris which reacts in many patients and causes infection-like responses, destroying bone, muscle, ligament and soft-tissues, leading to pain and dislocations of the hips. The metal can also seep into the blood and, in effect, cause a type of metal blood poisoning. The only way to stop the effects is to remove the metal cup and replace it with a traditional plastic lined cup.
The DePuy ASR implants are the subjects of thousands of lawsuits around the country. Most have been consolidated into a multi-district litigation based in the U.S. District Court for the Northern District of Ohio. However, many cases remaining pending in state courts throughout the U.S.
In related litigation, another DePuy metal-on-metal hip implant, the Pinnacle, has also seen cases consolidated in a multi-district litigation, this one in the Northern District of Texas. Generally, the same metal debris problems are occurring with the DePuy Pinnacle implants as occurred with the ASR implants.
For more information on the DePuy ASR Hip Implants, see my previous posts listed below. If you or a loved one have a DePuy ASR or DePuy Pinnacle implant, or suspect you have any metal-on-metal implant, call our offices immediately at 1-800-557-8176.
DePuy ASR Hip Implants Recalled
Hip Implants Withdrawn From Market
Metal on Metal Hip Components Linked to Early Failures