BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 1673206 · Received April 29, 2010

    Report

    Report Number
    1644408-2010-00223
    Event Type
    Other
    Date Received
    April 29, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 21, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    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 EXPERIENCING KNEE PAIN. PATELLA WAS NOT TRACKING PROPERLY. THE SURGEON CUT OFF 2MM OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE PATELLA, DOME, 35MM JWH ENCORE MEDICAL, L.P. 53944400

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention