BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 1853263 · Received September 30, 2010

    Report

    Report Number
    1644408-2010-00518
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    MBH
    PMA / PMN Number
    K032905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DOCTOR STATED THE SIZE 8, 3D POROUS FEMUR WAS OVERSIZED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE FEMUR MBH ENCORE MEDICAL, L.P. 455412M

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention