BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 5113558 · Received September 30, 2015

    Report

    Report Number
    3004153240-2015-00184
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 1, 2015
    Report Date
    February 16, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POLY INSERT DISLOCATION WAS REPORTED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    LATERAL POLY INSERT DISLOCATION WAS REPORTED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE RETRIEVED INSERTS WERE RETURNED FOR INVESTIGATION. MEASUREMENTS TAKEN FROM THE RETURNED INSERTS SUGGEST THAT THEY HAVE BEEN STEAM STERILIZED. THIS MAY HAVE OCCURRED AT THE HOSPITAL PRIOR TO RETURN FOR INVESTIGATION. THE MEDIAL INSERT APPEARED TO HAVE BONE CEMENT PRESENT IN THE AREA OF THE LOCKING MECHANISM. A SHEAR LINE WAS OBSERVED ON THE LOCKING TAB THAT MAY BE ATTRIBUTED TO EXTRACTION TOOLS USED DURING REVISION SURGERY. IT WAS REPORTED THAT THE MEDIAL INSERT WAS LOCKED IN PLACE AT THE TIME OF REVISION SURGERY. THE LOCKING TAB GEOMETRY ON BOTH THE MEDIAL AND LATERAL INSERTS APPEARED TO BE INTACT AND SHOULD HAVE ALLOWED FOR PROPER ASSEMBLY TO THE TIBIAL TRAY.

    Description of Event or Problem · 1

    POLY INSERT DISLOCATION WAS REPORTED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVISION SURGERY OCCURRED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644787 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention