DePuy Hip Replacements
DePuy Orthopaedics, a division of Johnson & Johnson, has recalled two types of hip implants because of early failures—at rates that appear to be about twice the industry average.
Included in the recall are the following:
- ASR XL Acetabular System, used for total hip replacements and FDA approved for the US
- ASR Hip Resurfacing System, which is used in a newer kind of bone-conserving procedure not officially available in the US as yet.
Some U.S. patients received the system through clinical trials or may have received ASR components in procedures done overseas. A combined total of about 93,000 of the devices have been implanted worldwide since they began being used in 2003.
DePuy issued the voluntary recall last fall when 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. The ASR systems fail much more often than others, according to Kevin J. Bozic, MD, an orthopedic surgeon and vice chairman of orthopedics 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.
In cases of hip implant failure, usually because of loosening, when the components detach from the bone, or from infection or dislocation, implants have to be removed and replaced in a revision surgery. Revisions are more complicated and costly than primary joint replacements because surgeons have less bone and more scar tissue to work with.
While swelling, pain and difficulty walking are all normal as part of recovery, when such symptoms continue beyond a reasonable period or start again after letting up for a while, this can be a sign an implant may be failing. Some people may also begin experiencing fever, nausea or other unexplained symptoms.
DePuy advises everyone who knows they have ASR implants to schedule follow-up appointments with their surgeons, even if they are not experiencing problems. This will allow doctors to evaluate how their implants are functioning. Doctors may also give patients blood tests to check for signs of microscopic metal particles around the implant, a sign of abnormal wear.
Understandably this recall has caused a lot of anxiety among people with hip replacements. Some patients have even asked to have their ASR implants removed, even though they have not been having trouble with them, because they fear future problems.
If you’re not sure whether you have an ASR hip replacement system or components, contact your orthopedic surgeon or the hospital where you had your surgery. Ask for the Operating Report which will list all the components of your hip system.
For more information about the recall, visit http://depuy.com/asr-hip-replacement-recall. The company will also take questions through a toll-free phone number: 888-627-2677.
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