BEUDAMED
    FDA Adverse Event Summary report: N

    3DKNEE

    MDR report key: 3063480 · Received April 17, 2013

    Report

    Report Number
    1644408-2013-00218
    Date Received
    April 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OIY
    PMA / PMN Number
    K091956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164468 3DKNEE E-PLUS INSERT, 9MM OIY ENCORE MEDICAL, L.P. 59602082

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention