BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 6975578 · Received October 25, 2017

    Report

    Report Number
    3004153240-2017-00233
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    October 1, 2017
    Report Date
    October 25, 2017
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K161366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE STERILE BARRIERS OF THE INNER AND OUTER POUCHES OF THE FEMORAL IMPLANT WERE COMPROMISED. THE FEMORAL IMPLANT WAS RE-STERILIZED. SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE BARRIERS OF THE INNER AND OUTER POUCHES OF THE FEMORAL IMPLANT WERE COMPROMISED. THE FEMORAL IMPLANT WAS RE-STERILIZED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755227 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR