BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 6134409 · Received November 30, 2016

    Report

    Report Number
    3004153240-2016-00235
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REASON FOR REVISION IS UNKNOWN AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERTS. REASON FOR REVISION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787231 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention