BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP METAL ON METAL LINER

    MDR report key: 1080991 · Received July 23, 2008

    Report

    Report Number
    1644408-2008-00223
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY- LINER WAS REPLACED DUE TO PROBLEMS WITH DISLOCATION. A NEW 20 DEGREE HXL LINER WAS PUT IN TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP METAL ON METAL LINER ACETABULAR LINER KWB ENCORE MEDICAL, L.P. 53862173

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention