BEUDAMED
    FDA Adverse Event Other Summary report: N

    X-ALT HIP

    MDR report key: 1943559 · Received December 6, 2010

    Report

    Report Number
    1644408-2010-00645
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE HOOD ON ACETABULAR WAS IMPLANTED INCORRECTLY. A SUPERIOR HOOD WAS IMPLANTED INFERIORLY CAUSING DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-ALT HIP ACETABULAR HOODED LINER KWA ENCORE MEDICAL, L.P. 53943964

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 010-55-035, LOT 54014679| 010-55-040, LOT 53999905