J&J Hip Replacement Shows Failure Rate of 49 Percent

Nearly half the patients that receive a controversial hip replacement system from DePuy Orthopaedics Inc. eventually need revision surgery, more than triple the failure rate the company cited last year, according to recent data.

The rate of second hip replacement procedures with DePuy’s ASR XL Acetabular System ranges from 21 percent after four years to 49 percent after six years in the United Kingdom, information from four surgeons indicate. The surgeons presented the data last week at the British Hip Society Annual Conference in Torquay, England. Last year, DePuy recalled its ASR system, citing a failure rate of 13 percent.

The doctors’ data concluded that use of large diameter metal-on-metal bearings in primary total hip replacement should be carefully considered and possibly avoided. The statement addressed only large diameter metal-on-metal implants but the doctors did not define “large diameter.”

John Skinner, chairman of the Medicines and Healthcare products Regulatory Products’ expert advisory group on metal bearing hips, said the information likely is the best indicator so far of what the failure rate is likely to be (the data have not yet undergone the peer review required for publication). In addition, the expert advisory group said the revision rate at four years possibly could rise to 35 percent if all currently known painful implants need to be replaced.

“The results were at a level where we thought it was best to act now,” Skinner said. “The purpose is to tell British surgeons that the ASR XL patients are likely to have a higher rate of revision on the basis of this data, if it turns out to be correct.”

To date, 600 lawsuits have been filed in the United States against Johnson &Johnson (DePuy’s parent company) because of the device. Product liability, negligence and failure-to-warn claims have been filed in Ohio, California and New Jersey.

J&J is based in New Brunswick, N.J. DePuy was purchased for $3.5 billion in 1998. DePuy’s artificial hip sales declined after the first recall of the ASR XL Acetabular System and the ASR hip resurfacing system in August of 2010; the company took a $280 million charge in the fourth quarter to pay for the recall.

In an emailed statement, DePuy spokeswoman Mindy Tinsley said, “DePuy remains committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”