BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE ACETABULAR SYSTEMS

    MDR report key: 1061731 · Received June 16, 2008

    Report

    Report Number
    1644408-2008-00187
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY-FAILED ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE ACETABULAR SYSTEMS ACETABULAR SHELL, FLARED KWB ENCORE MEDICAL, L.P. 139631

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 400-02-252| (SCREWS)| (HEAD)