BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 4223762 · Received October 30, 2014

    Report

    Report Number
    3004153240-2014-00143
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K131019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL INTERVENTION OCCURRED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REASON FOR SURGERY IS UNKNOWN. THE DEVICE REMAINS IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    SURGICAL INTERVENTION OCCURRED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REASON FOR SURGERY IS UNKNOWN. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694648 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR