BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 12 CROSSFIRE 0 DEG 28MM

    MDR report key: 557825 · Received December 2, 2004

    Report

    Report Number
    2249697-2004-00141
    Event Type
    Injury
    Date Received
    December 2, 2004
    Date of Event
    November 3, 2004
    Report Date
    November 4, 2004
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A PRIMARY THR IN 02/2002 FOR DJD. #3 ACCOLADE STEM AND 58MM OSTEOLOCK CUP IMPLANTED, WELL POSITIONED WITH GOOD FIT AND FILL. PT UNDERWENT REVISION OF FEMORAL COMPONENT FOR LOOSENING AND POLYETHYLENE LINER CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 12 CROSSFIRE 0 DEG 28MM IMPLANT KWB STRYKER ORTHOPAEDICS MAHWAH NA VVTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention