Arthritis Self-Management

Two Hip Replacement Implants Are Recalled

by David W. Golann
September 2, 2010

Two types of hip replacement implants have been recalled because they fail more often than expected. DePuy Orthopaedics, a unit of Johnson & Johnson, announced the voluntary recall on August 26, citing data that 1 in 8 people with the implants have had to have them surgically replaced within five years.

The recalled implants are the ASR XL Acetabular System, which is used in a total hip replacement, and the ASR Hip Resurfacing System, which is used for hip resurfacing. The ASR XL Acetabular System has been available in the United States since 2005, but the ASR Hip Resurfacing System has been used only in clinical trials (it is also available in some foreign countries). According to DePuy, about 93,000 hip replacements with the ASR XL Acetabular System have been performed worldwide.

Unpublished data from the National Joint Registry of England and Wales found that 13% of people who had the ASR XL Acetabular System and 12% who had the ASR Hip Resurfacing System needed to have surgery to replace their original implant within five years of the initial surgery. The United States does not have a comparable registry of joint replacement surgeries.

Total hip replacement and hip resurfacing differ in key ways. In a total hip replacement, both the top of the thighbone (the “ball”) and the concave part of the pelvis (the “socket”) are removed and replaced with synthetic (either ceramic or metal) parts. In hip resurfacing, the hip socket is replaced, but the end of the thighbone is only shaved down and resurfaced, or “capped,” with a synthetic material. Hip resurfacing is a newer procedure designed to preserve bone in the hip, making it easier to perform a total hip replacement later. For this reason, it may be a good option for younger people, who are more likely to need to replace their original implant later in life. However, there is no long-term data on the safety and effectiveness of hip resurfacing surgeries.

Most total hip replacements can be expected to last 20 or more years. However, they are susceptible to complications. Infections can occur in the replacement joint within the first days or weeks of the procedure, and can also occur months or years after the surgery. Because it is difficult to “wash” bacteria out of a replacement joint, an infection in the joint often requires that the implant be replaced. An implant can also loosen over time through use or because of faulty implantation or design. In rare cases, a hip implant can dislocate or cause a bone in or around the hip to fracture. DePuy cited all these potential problems as causes of the failure of their implants.

If you have had a hip replacement and are not sure whether your implant is included in the recall, contact your orthopedic surgeon. If you don’t remember who that is, get in touch with your primary-care doctor. If that fails, you can fill out a release form on the DePuy Web site so that the company can investigate whether you have a recalled implant.

If you find out that you have a recalled implant, schedule an appointment with your orthopedic surgeon. The surgeon may take an x-ray to determine how the implant is positioned and a blood test to detect any metal particles in the blood. (These particles are a sign that the implant has been subject to unusual wear.) The recall does not mean that all people who have these types of hip replacements will need them replaced — the majority of the implants still work well. Still, people who do not have their implant replaced should plan to see their orthopedic surgeon yearly to monitor the condition of the replacement hip.

DePuy has said it will reimburse people for “reasonable and customary” out-of-pocket costs related to the recall, including for necessary replacement surgeries. Call DePuy at (888) 627-2677 for more information.

David W. Golann is the Associate Editor of Arthritis Self-Management.

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