BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 2081806 · Received May 3, 2011

    Report

    Report Number
    MW5020509
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) FEMALE HAVING HER PREVIOUSLY IMPLANTED DEPUY ASR HIP ASR XL ACETABULAR SYSTEM REMOVED FOR FAILED RIGHT TOTAL HIP REPLACEMENT. DEPUY ORTHOPAEDICS ISSUED A VOLUNTARY RECALL OF ITS ASR SL ACETABULAR SYSTEM OR DEPUY ASR HIP RESURFACING SYSTEM ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL ACETABULAR SYSTEM KWA DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability