When DePuy Orthopedics issued recalls for the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System last August, the company said data from the National Joint Registry of England and Wales indicated that 1 out of every 8 patients (12%-13%) had to undergo revision surgery within five years of receiving the defective devices. But according to a Bloomberg report, doctors in the United Kingdom (U.K.) say they're seeing early failures of the ASR XL Acetabular Hip Replacement System at a rate closer to 50 percent.
A statement issued this week by the British Orthopaedic Association and British Hip Soceity said data from four surgeons shows the rate of revision surgeries in patients who received the DePuy ASR XL Acetabular Hip Replacement System ranges from 21 percent after four years to 49 percent after six years. The statement went on to say that the 21 percent revision rate at 4 years could rise to 35 percent "if all currently known painful implants progress to revision," Bloomberg said. Only the ASR XL was approved for sale in the U.S., where 37,000 were implanted.
The orthopedists didn't report on the resurfacing system in the statement, which was not sold in the U.S., according to Bloomberg. The statement also limits its commentary to large diameter implants, without defining "large diameter." Bloomberg noted that DePuy's original recall notice said that revision rates would probably be highest for ASR head sizes less than 50 millimeters in diameter, which are normally used in female patients.
According to Bloomberg, more than 350 lawsuits involving the recall have been consolidated in the MDL, more than 220 more are pending in California state court, and another group of cases is pending in New Jersey state court.