BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKA KNEE

    MDR report key: 1820102 · Received August 24, 2010

    Report

    Report Number
    1644408-2010-00455
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUTTING BLOCK KNEE INSTRUMENT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKA KNEE SPEEDBLOCK, FEMORAL LXH ENCORE MEDICAL, L.P. 32377L21

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR