BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL G2

    MDR report key: 4925749 · Received July 16, 2015

    Report

    Report Number
    3004153240-2015-00134
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 25, 2015
    Manufacturer
    CONFORMIS
    Product Code
    OIY
    PMA / PMN Number
    K142161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED AN INFECTION. REVISION SURGERY WAS SCHEDULED TO EXCHANGE THE POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPEC. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN INFECTION. REVISION SURGERY WAS SCHEDULED TO EXCHANGE THE POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463772 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM OIY CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention