BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 2902919 · Received November 29, 2012

    Report

    Report Number
    3004153240-2012-00112
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROVIDED LATERAL POLY INSERTS WOULD NOT LOCK INTO THE TRAY DURING SURGERY. THE SURGEON TRIMMED THE BACK OF THE LATERAL POLY USING A SAW BLADE AND IMPLANTED THE POLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MFG TO SPECIFICATION.

    Description of Event or Problem · 1

    THE PROVIDED LATERAL POLY INSERTS WOULD NOT LOCK INTO THE TRAY DURING SURGERY. THE SURGEON TRIMMED THE BACK OF THE LATERAL POLY USING A SAW BLADE AND IMPLANTED THE POLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR