BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 2222852 · Received August 10, 2011

    Report

    Report Number
    1644408-2011-00453
    Event Type
    Other
    Date Received
    August 10, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS EXPERIENCING PAIN, THE DOCTOR FOUND THE FEMORAL COMPONENT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE DCM INSERT, 15MM JWH ENCORE MEDICAL, L.P. 59600256

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 233-02-104, LOT # 903A1003