BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP SYSTEM

    MDR report key: 1202766 · Received October 13, 2008

    Report

    Report Number
    1644408-2008-00351
    Event Type
    Other
    Date Received
    October 13, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - NO MEDIAL WALL FIXATION IN THE ACETABULUM, SHELL COMPONENT REPLACED WITH MULTIHOLE SHELL AND MULTIPLE FIXATION SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP SYSTEM ACETABULAR SHELL, HEMI KWB ENCORE MEDICAL, L.P. 53927185

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 432-32-210