Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant. Hip replacement surgery can be performed as a total replacement or a hemi (half) replacement. Such joint replacement orthopaedic surgery generally is conducted to relieve arthritis pain or fix severe physical joint damage as part of hip fracture treatment. A total hip replacement (total hip arthroplasty) consists of replacing both the acetabulum and the femoral head while hemiarthroplasty generally only replaces the femoral head. Hip replacement is currently the most successful and reliable orthopaedic operation[citation needed] with 97% of patients reporting improved outcome.

This recall came after data from a recent study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. The defective and dangerous replacement hips have already been implanted in patients. The recall means that patients who have already undergone one surgical procedure to replace a hip may have to undergo a “revision.” That is: a second surgery. But even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that might not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the DePuy ASR XL Acetabular hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.

The DePuy ASR XL Acetabular System first became available in 2005 in the United States. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. But since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.

At the beginning of 2010 DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2010 the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate.[1] However at this point they still had not issued a recall of the product. In fact, they adamantly denied there was a recall and claimed any statements referencing a recall were false.[3]

Johnson and Johnson has experienced other recall issues this year and DePuy Orthopaedics is barely three years removed from a scandal that involved undisclosed payments to doctors.

It remains to be seen how DePuy’s recent recall, which affects the ASR XL Acetabular System and the ASR Hip Resurfacing System, will affect the company financially. Lawsuits are now being filed, since it was determined that the ASR devices fail in 1 out of 8 patients, making a second hip replacement surgery necessary. Recipients are suing the manufacturer for the costs associated with this “revision” surgery, as well as for pain and suffering in some instances. 93,000 persons worldwide received an ASR implant, making it likely that DePuy will face many thousands of lawsuits.

The first lawsuit in the United States against DePuy Orthopaedics was filed on June 15, 2010. The lawsuit claims that the DePuy ASR hip replacement was defectively designed, that DePuy knew that there were problems with the implant early on but didn’t do anything to let patients or their surgeons know about the possible problems. The United States Judicial Panel on MultiDistrict Litigation filed a ruling on December 7, 2010[4] that determined the fate of the thousands of lawsuits regarding DePuy Hip Recalls in the United States. Its ruling stated that all cases filed across the country, “are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings.”

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