Two Hip Replacement Implants Recalled
About 1 in 8 people with ASR components has needed corrective surgery within five years.
DePuy Orthopaedics, a division of Johnson & Johnson, has announced that it is recalling two types of hip implants because of higher-than-expected early failure rates.
The recall affects the ASR XL Acetabular System, which is used for total hip replacements, and the ASR Hip Resurfacing System, which is used in a newer kind of bone-conserving procedure.
The total hip replacement system was FDA approved and has been used in patients in the United States.
The hip resurfacing system has not been approved for use in this country, but according to company spokeswoman Lorie Gawreluk, some patients in the U.S. have gotten the implants through a clinical trial.
Also, people who have traveled outside of the U.S. for hip resurfacing or hip replacement procedures may have been fitted with ASR components.
A combined total of about 93,000 of the devices have been implanted worldwide.
DePuy said that it was issuing the voluntary recall after new data from a British joint replacement registry showed about 1 in 8, or around 12 percent, of those who received the implants needed corrective procedures, called revision surgeries, within five years.
That failure rate appears to be about twice the industry average, says Kevin J. Bozic, MD, an orthopaedic surgeon and vice chairman of orthopaedics at the University of California at San Francisco Medical Center, who has studied revision rates in hip replacement.
“It was a design failure that frankly wasn’t picked up until they were implanted in thousands of patients,” Dr. Bozic says.