BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE INSTRUMENTATION

    MDR report key: 1575620 · Received December 21, 2009

    Report

    Report Number
    1644408-2009-00592
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 7, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RIGHT TKA, SEVERE DJD, RIGHT KNEE. THE TRIAL PLASTIC CRACKED WHEN SURGEON WENT TO REMOVE IT AFTER BRINGING THE PT THROUGH ROM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR