BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDUO G2

    MDR report key: 4781808 · Received May 15, 2015

    Report

    Report Number
    3004153240-2015-00085
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 15, 2015
    Manufacturer
    CONFORMIS, INC.
    Product Code
    NPJ
    PMA / PMN Number
    K093513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIBIAL COMPONENT HAS SHIFTED. REVISION SURGERY IS PLANNED TO EXCHANGE THE TIBIAL TRAY AND POLY INSERTS. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE TIBIAL COMPONENT HAS SHIFTED. REVISION SURGERY IS PLANNED TO EXCHANGE THE TIBIAL TRAY AND POLY INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318253 IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT NPJ CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention