BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR

    MDR report key: 2211499 · Received August 9, 2011

    Report

    Report Number
    MW5021717
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARDWARE REMOVED AND TOTAL HIP REVISION SURGERY COMPLETED FOR HARDWARE FAILURE. RECALLED DEPUY ASR HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR ASR ACETABULAR COMPONENT KWA DEPUY
    2 DEPUY ASR FEMORAL NECK COMPONENT KXA DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability