subject: Victims Determine Identity Of Depuy Hip Replacement Received In Light Of Fda Enforcement Report [print this page] The Rottenstein Law Group is reiterating its recommendation that victims of confirm the identity of their hip implants after the FDA enumerated product unit codes in a recent report.
In an enforcement report dated October 13, 2010, the U.S. Food and Drug Administration listed 29 different DePuy ASR-model hip replacement implants recalled by the manufacturer. The products all fall into two series: ASR 100 and ASR 300. Within the ASR 100 series, there are fifteen models ranging in size from 44mm to 70mm; the ASR 300 series products have the same size range. The report puts the number of recalled DePuy ASR units in commerce in the United States at 36,486.
The report summarizes the state of the recall as follows: 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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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.
DePuy does not have records indicating who has received ASR device. Any recipient of a hip implant since 2003 is advised to speak with his or her doctor to determine whether the device implanted is a recalled DePuy ASR unit.
