subject: FDA Enforcement Report Illustrates Magnitude of DePuy's Hip Replacement Recall [print this page] FDA Enforcement Report Illustrates Magnitude of DePuy's Hip Replacement Recall
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. 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 recall, stating the following:
"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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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."
In other words, DePuy issued the hip replacement recall because the revision rate for units with smaller cup sizes was greater than what everyone expected. It is known that overall, the likelihood of revision for both replacement hips is roughly 12% within five years.
Replacement hips of larger cup sizes tend to be revised no more frequently than others and for the same reasons. The report states:
"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."
Nowhere in the FDA's report does it refer to metallosiscobalt and chromium poisoning caused by the hip implant's metal ions. Metallosis is one of the gravest risks caused by DePuy's recalled hip replacements. It can cause severe, permanent damage if the defective implant is not removed.
The Rottenstein Law Group will always stay abreast of the DePuy hip replacement recall. Finding out precisely which cup you or loved one was implanted with will factor into the recovery you can obtain from DePuy. When you know the type of hip replacement cup you have, contact one of our attorneys to evaluate your case.
