BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE SYSTEM

    MDR report key: 1053296 · Received May 28, 2008

    Report

    Report Number
    1644408-2008-00173
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY- LAXITY IN KNEE, LOOSE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE SYSTEM FEMUR, POROUS HSH ENCORE MEDICAL, L.P. 436292T

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 391-11-608/462372