DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK that demonstrated the ASR™ System had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter).
DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent and for the ASR™ XL Acetabular System is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patient.
Because the new NJR data shows a higher than expected revision rate at five years, DePuy is issuing a voluntary recall of all ASR products.
Do not implant the ASR devices.
Per the April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions to metal wear debris. The debris can cause soft tissue damage which may compromise the results of the revision surgery. Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome.