On October 13, 2010, the U.S. Food and Drug Administration released a report detailing the extent of DePuy’s recall of its two metal-on-metal hip replacements, the ASL XL Acetabular System and the ASL Hip Resurfacing System. (To see model numbers click here to go to the FDA Enforcement Report). The report divides the recalled implants into two series: the ASR 100 and the ASR 300. The ASR 100 series accounts for 15 models designed to accommodate various hip cup diameters, from 44mm to 70mm. The ASR 300 series includes the remaining 14 models, also defined by diameters of the same range. At the time of the report, 36,486 units were still in commerce
The FDA characterized the DePuy recall as follows:
REASON
Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-market surveillance activities, the firm recently received and analyzed new data regarding the ASR platform which suggests a higher than expected revision rate for the ASR XL Monoblock Metal-on-Metal (MoM) System linked to usage of monoblock MoM cups with corresponding head sizes below 50mm in diameter. As a result of the findings, DePuy Orthopaedics issued a Field Safety Notice to share the new data with the surgeons and reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorship. Reasons for revision are typical for the class of large diameter MoM monoblock cups and includes component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity.
VOLUME OF PRODUCT IN COMMERCE
36,486 units
DISTRIBUTION
Nationwide
The report was silent as to the contamination from metal known as metalosis that presents a significant risk to thousands of users. For more information on whether your device puts you at risk feel free to contact a DePuy lawyer at The Brandi Law Firm