BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE INSTRUMENT

    MDR report key: 2102073 · Received April 14, 2011

    Report

    Report Number
    1644408-2011-00189
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE SURGEON HAS TROUBLE PUTTING IN ANY NEW TRIAL. HE HAS PLAYED WITH NEWER TRIALS AND THEY APPEAR TO HAVE A DESIGN ISSUE THAT MAKES IT DIFFICULT TO PUSH BACK INTO THE BASEPLATE TRIAL UNDER THE COMPRESSION OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSTRUMENT TIBIAL PRIMARY CURVED INSERT TRIAL LXH ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 801-01-440: LOT NA