BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 509306 · Received January 23, 2004

    Report

    Report Number
    1644408-2004-00001
    Event Type
    Other
    Date Received
    January 23, 2004
    Date of Event
    November 1, 2003
    Report Date
    January 16, 2004
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION OF TIBIAL INSERT DUE TO BROKEN POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM PS TIBIAL INSERT HSH ENCORE MEDICAL, L.P. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention