BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKA KNEE INSTRUMENT

    MDR report key: 2180845 · Received April 28, 2011

    Report

    Report Number
    1644408-2011-00240
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE BALL BEARING IN THE GUIDE IS WORN, THE IM BUSHINGS FALL OUT OF THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKA KNEE INSTRUMENT DISTAL FEMORAL CUT GUIDE JWH ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1