BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 3080767 · Received April 9, 2013

    Report

    Report Number
    3004153240-2013-00064
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 7MM MEDIAL POLY INSERT LIFTED FROM THE TRAY ANTERIORLY WHEN THE KNEE WAS BROUGHT THROUGH RANGE OF MOTION INTRAOPERATIVELY. THE 8MM MEDIAL POLY INSERT WAS IMPLANTED. THE 8MM POLY INSERT REMAINED SEATED THROUGH RANGE OF MOTION TESTING. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPEC.

    Description of Event or Problem · 1

    THE 7MM MEDIAL POLY INSERT LIFTED FROM THE TRAY ANTERIORLY WHEN THE KNEE WAS BROUGHT THROUGH RANGE OF MOTION INTRAOPERATIVELY. THE 8MM MEDIAL POLY INSERT WAS IMPLANTED. THE 8MM POLY INSERT REMAINED SEATED THROUGH RANGE OF MOTION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148093 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR