BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 3080766 · Received April 9, 2013

    Report

    Report Number
    3004153240-2013-00063
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LATERAL A POLY DISASSOCIATED FROM THE TIBIAL TRAY WHEN THE KNEE WAS BROUGHT THROUGH ROM DURING SURGERY. SURGEON BURRED 2MM OFF THE POSTERIOR LIP OF THE POLY AND INSERTED IT. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO KNOWN ADVERSE EFFECT AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPEC.

    Description of Event or Problem · 1

    THE LATERAL A POLY DISASSOCIATED FROM THE TIBIAL TRAY WHEN THE KNEE WAS BROUGHT THROUGH ROM DURING SURGERY. SURGEON BURRED 2MM OFF THE POSTERIOR LIP OF THE POLY AND INSERTED IT. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. NO KNOWN ADVERSE EFFECT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144832 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR