BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE SYSTEM

    MDR report key: 1001900 · Received February 25, 2008

    Report

    Report Number
    1644408-2008-00044
    Event Type
    Other
    Date Received
    February 25, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - KNEE JOINT LOOSE IN EXTENSION AND FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE SYSTEM TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 53799247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 333-02-| 233-02-