BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 2953898 · Received January 14, 2013

    Report

    Report Number
    3004153240-2013-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 15, 2012
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LATERAL A POLY LIFTED UP ANTERIORLY WHEN THE SURGEON BROUGHT THE KNEE THROUGH RANGE OF MOTION FOLLOWING POLY INSERTION DURING SURGERY. THE INSERT LIFTED UP ANTERIORLY WITH THE KNEE AT 110 DEGREES FLEXION. THE SURGEON ATTEMPTED TO INSERT THE LATERAL B POLY. THE INSERT LIFTED UP ANTERIORLY WITH THE KNEE AT 110 DEGREES FLEXION. SURGERY WAS COMPLETED USING THE LATERAL A POLY INSERT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. RETURNED DEVICE EVALUATION: THE LATERAL B POLY INSERT THAT WAS NOT IMPLANTED DURING SURGERY WAS RETURNED TO CONFORMIS FOR EVALUATION. A HORIZONTAL IMPRESSION WAS OBSERVED ACROSS THE SNAP FEATURE OF THE LOCKING MECHANISM. IT APPEARS THAT THE INSERT WAS NOT PROPERLY ALIGNED WITH THE TRAY WHEN IMPACTION FORCE WAS APPLIED DURING POLY INSERTION. THIS DAMAGE MAY HAVE PREVENTED THE LOCKING MECHANISM FROM FULLY ENGAGING.

    Description of Event or Problem · 1

    THE LATERAL A POLY LIFTED UP ANTERIORLY WHEN THE SURGEON BROUGHT THE KNEE THROUGH RANGE OF MOTION FOLLOWING POLY INSERTION DURING SURGERY. THE INSERT LIFTED UP ANTERIORLY WITH THE KNEE AT 110 DEGREES FLEXION. THE SURGEON ATTEMPTED TO INSERT THE LATERAL B POLY. THE INSERT LIFTED UP ANTERIORLY WITH THE KNEE AT 110 DEGREES FLEXION. SURGERY WAS COMPLETED USING THE LATERAL A POLY INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19739 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR