BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIK KNEE

    MDR report key: 1736324 · Received June 23, 2010

    Report

    Report Number
    1644408-2010-00340
    Event Type
    Other
    Date Received
    June 23, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UNI-KNEE FEMORAL GUIDE HANDLE INSTRUMENT BROKE IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIK KNEE FEMUR CUT GIDE, HANDLE FZX ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1