BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL

    MDR report key: 2821349 · Received October 25, 2012

    Report

    Report Number
    3004153240-2012-00093
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K103117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WITH A TOTAL KNEE IMPLANT DEVELOPED AN INFECTION. SURGICAL INTERVENTION IS PLANNED TO EXCHANGE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    PATIENT WITH A TOTAL KNEE IMPLANT DEVELOPED AN INFECTION. SURGICAL INTERVENTION IS PLANNED TO EXCHANGE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITOTAL TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R