Depuy Orthopaedics, a division of Johnson & Johnson has recalled an often used hip replacement implant. The implant in question is the ASR XL Acetabular System, an artificial hip socket used in traditional hip replacements. The FDA first cleared the ASR implant in 2005 for use in traditional hip replacements, but did not require it to undergo clinical trials because it was claimed that the implant was substantially similar to other implants already on the market.
But the FDA began to receive complaints about the early failures more than two years ago. Johnson & Johnson warned orthopedists as early as March, 2010 of the higher failure rate and even stopped selling the implants, but only issued a recall in August, 2010.
The ASR implant has been used worldwide for some time and recent studies, particularly in Australia, indicate that it has a significantly higher early failure rate then other manufacturers’ devices.
The ASR implant has what are known as metal on metal bearings and some experts believe that the metallic debris caused by metal on metal friction causes inflammation and tissue damage in some patients. Other specialists are of the opinion that the ASR implant contains a design defect that makes it difficult for an orthopedic surgeon to position during surgery.
As a result of these problems, recent data indicates that approximately 13% of patients who have received the ASR implant needed to have revision surgery.