BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 3964127 · Received July 11, 2014

    Report

    Report Number
    3004153240-2014-00092
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K131019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED POST-OPERATIVELY THAT CEMENT PARTICLES WERE PRESENT IN THE KNEE. RE-OPERATION IS PLANNED TO REMOVE THE CEMENT PARTICLES AND EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS IDENTIFIED POST-OPERATIVELY THAT CEMENT PARTICLES WERE PRESENT IN THE KNEE. RE-OPERATION IS PLANNED TO REMOVE THE CEMENT PARTICLES AND EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408059 ITOTAL G2 TOTAL KNEE REPLACEMENT SYS JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention