BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I DUO G2

    MDR report key: 4906118 · Received July 7, 2015

    Report

    Report Number
    3004153240-2015-00121
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 30, 2015
    Manufacturer
    CONFORMIS
    Product Code
    NPJ
    PMA / PMN Number
    K093513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY IS OCCURRING FOR PATIENT WITH AN IDUO IMPLANT DUE TO CONTINUAL PAIN. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION SURGERY IS OCCURRING FOR PATIENT WITH AN IDUO IMPLANT DUE TO CONTINUAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441001 I DUO G2 BICOMPARTMENTAL KNEE REPLACEMENT NPJ CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention