BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 2944220 · Received January 10, 2013

    Report

    Report Number
    3004153240-2013-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K120316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE MEDIAL 6MM AND LATERAL A POLY INSERTS LIFTED UP FROM THE TIBIAL TRAY WHEN THE KNEE WAS BROUGHT INTO DEEP FLEXION DURING SURGERY. THE CASE WAS COMPLETED USING THE MEDIAL 7MM AND LATERAL B POLY INSERTS. THE LATERAL B POLY INSERT IS 1MM THICKER THAN THE LATERAL A POLY INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14123 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM HSX CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR