BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERAMOS CERAMIC ON CERAMIC ACETABULAR LINER

    MDR report key: 1220567 · Received October 31, 2008

    Report

    Report Number
    1644408-2008-00397
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    PMA / PMN Number
    D980003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - SHELL VERTICLE, CHANGE MODULAR NECK, LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERAMOS CERAMIC ON CERAMIC ACETABULAR LINER ACETABULAR LINER KWB ENCORE MEDICAL, L.P. 004642

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 400-01-291/247252K| 410-32-112/1950