BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 3911583 · Received June 27, 2014

    Report

    Report Number
    3004153240-2014-00080
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OCCURRED TO EXCHANGE THE PLY INSERTS WITH POLY INSERTS OF A THICKER SIZE IN ORDER TO TIGHTEN THE JOINT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS WITH POLY INSERTS OF A THICKER SIZE IN ORDER TO TIGHTEN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376342 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention