BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 6072157 · Received November 2, 2016

    Report

    Report Number
    3004153240-2016-00222
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K131019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL IMPLANT LOOSENING WAS REPORTED. REVISION SURGERY OCCURRED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    TIBIAL IMPLANT LOOSENING WAS REPORTED. REVISION SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725077 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention