BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 1230276 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00411
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING KNEE PAIN. ORIGINAL POLY WAS REMOVED AND REPLACED WITH A LARGER SIZE INSERT AND PATELLA OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 895901A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 130-03-029, LOT# 221922