BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 5113551 · Received September 30, 2015

    Report

    Report Number
    3004153240-2015-00183
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 30, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PRESENTED WITH PAIN AND DISCOMFORT IN THE JOINT. SURGEON IDENTIFIED THAT THE KNEE WAS INFECTED AND DEVELOPED SEPSIS. SURGERY OCCURRED TO WASH OUT THE JOINT. ALL IMPLANTED COMPONENTS WERE LEFT IN PLACE. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PAIN AND DISCOMFORT IN THE JOINT. SURGEON IDENTIFIED THAT THE KNEE WAS INFECTED AND DEVELOPED SEPSIS. SURGERY OCCURRED TO WASH OUT THE JOINT. ALL IMPLANTED COMPONENTS WERE LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646048 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention