BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERAMOS

    MDR report key: 656183 · Received December 19, 2005

    Report

    Report Number
    1644408-2005-00064
    Event Type
    Other
    Date Received
    December 19, 2005
    Date of Event
    November 14, 2005
    Report Date
    December 15, 2005
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PIECES OF POROUS COATING ON THE RIM FELL OFF DURING SURGERY. DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERAMOS ACETABULAR SHELL KWB ENCORE MEDICAL, L.P. * 276202

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other