BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 2992837 · Received February 27, 2013

    Report

    Report Number
    3004153240-2013-00032
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL INTERVENTION OCCURRED FOR PT WITH AN ITOTAL IMPLANT. AT THE TIME OF SURGERY, THE LATERAL INSERT WAS OBSERVED TO BE LOOSE. THE SURGEON REMOVED THE INSERT, CLEANED THE INSERT AND TRAY, AND RE-INSERTED THE INSERT. FOLLOWING THIS PROCEDURE DURING POST-OPERATIVE VISIT, PT WAS UNABLE TO GAIN FULL EXTENSION. REVISION SURGERY IS PLANNED TO EXCHANGE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    SURGICAL INTERVENTION OCCURRED FOR PT WITH AN ITOTAL IMPLANT. AT THE TIME OF SURGERY, THE LATERAL INSERT WAS OBSERVED TO BE LOOSE. THE SURGEON REMOVED THE INSERT, CLEANED THE INSERT AND TRAY, AND RE-INSERTED THE INSERT. FOLLOWING THIS PROCEDURE DURING POST-OPERATIVE VISIT, PT WAS UNABLE TO GAIN FULL EXTENSION. REVISION SURGERY IS PLANNED TO EXCHANGE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83588 ITOTAL TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention