BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ASR ACETABULAR CUP SIZE 56

    MDR report key: 1922916 · Received October 20, 2010

    Report

    Report Number
    1922916
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF DEPUY ASR ACETABULAR COMPONENT, DEPUY ASR UNIFEMORAL HEAD IMPLANT AND DEPUY ASR TAPER SLEEVE ADAPTER APPROXIMATELY 2 YEARS AFTER IMPLANT DUE TO DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR ACETABULAR CUP SIZE 56 ARTIFICIAL HIP KWA DEPUY 2703694
    2 DEPUY TAPERED HIP STEM W/POROCOAT ARTIFICIAL HIP KXA DEPUY C5AC21000
    3 DEPUY ASR TAPER SLEEVE ADAPTOR ARTIFICIAL HIP KXA DEPUY 2762419
    4 DEPUY ASR UNIFEMORAL IMPLANT SIZE 49 ARTIFICIAL HIP KXA DEPUY 2706368

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR