BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL

    MDR report key: 2826189 · Received October 17, 2012

    Report

    Report Number
    3004153240-2012-00090
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 18, 2012
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K103117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LATERAL C POLY INSERT AND LATERAL B POLY INSERT WOULD NOT LOCK INTO THE TIBIAL TRAY DURING SURGERY. THE LATERAL A POLY INSERT WAS USED TO COMPLETE THE SURGERY. THE LATERAL A POLY INSERT IS 1MM THINNER THAN THE LATERAL B POLY INSERT AND 2MM THINNER THAN THE LATERAL C POLY INSERT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. RETURNED DEVICE EVALUATION: THE LATERAL B AND LATERAL C POLY INSERTS WERE RETURNED FOR EVALUATION/ PHYSICAL EXAMINATION OF THE RETURNED INSERTS SHOWS SIGNIFICANT DAMAGE TO THE SNAP FEATURE OF THE LOCKING MECHANISM. EXAMINATION INDICATES THAT THE POLY INSERTS MAY NOT HAVE BEEN ALIGNED PROPERLY AT THE TIME OF IMPACTION. WITH THE INSERTS DAMAGED IN THIS MANNER, IT IS LIKELY THAT THE INSERTS WERE NOT ABLE TO COMPLETELY LOCK INTO THE TRAY.

    Description of Event or Problem · 1

    THE LATERAL C POLY INSERT AND LATERAL B POLY INSERT WOULD NOT LOCK INTO THE TIBIAL TRAY DURING SURGERY. THE LATERAL A POLY INSERT WAS USED TO COMPLETE THE SURGERY. THE LATERAL A POLY INSERT IS 1MM THINNER THAN THE LATERAL B POLY INSERT AND 2MM THINNER THAN THE LATERAL C POLY INSERT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR