ASR XL Acetabular System Recalled For Its Excessive Failure Rate

In the midst of an onslought of recalls by Johnson and Johnson, and a mere two days after the FDA issued a warning letter in which the FDA advised DePuy that two of its product are misbranded, DePuy Orthopaedics,  a Johnson and Johnson company, announced a recall for the ASR XL Acetabular hip replacement system.

As reported in the Wall Street Journal, the failure rate of the ASR XL is 13% compared to the average 5% failure rate.

The failure rate of the ASR XL  Acetabular System has forced a large number of patients to undergo a second hip replacement procedure, known as a revision surgery.  According to the Wall Street Journal, as , which is troubling given that many implant patients may not even experience any symptoms alerting them that there is a problem.

While signs that there may be a problem with ASR XL hip replacement include swelling, pain, and difficulty walking, the ASR XL metal on metal design is problematic. The device can generate metal debris or particles which dislodge from the implant and travel into the bloodstream of unsuspecting patients.

An X-ray or imaging scan will allow your orthopaedic surgeon to check the progress of the implant, and a blood test can determine if any metal debris is present in your bloodstream requiring a revision surgery.  Even if you do not notice any immediate problems, Johnson and Johnson is recommending peliautomaatti that implant patients undergo yearly monitoring to check for problems which may require a revision surgery.

Side Effects of a Revision Surgery

Even if  DePuy covers the “reasonable and customary” costs of a revision surgery, consumers should be forewarned.

Revision surgeries are technically more difficult, take longer to perform, place you at risk of higher complications,  and take longer to recover from.  In addition, any type of surgery places you at risk for infection, complications, or even risk of death.

If you or a loved one has had a revision surgery or problems with the ASR XL hip replacement system, contact the hip replacement attorneys at The Strom Law Firm, LLC today for a free consultation to discuss the facts related to your hip replacement and how we can help.