BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDUO G2

    MDR report key: 2409944 · Received January 6, 2012

    Report

    Report Number
    3004153240-2012-00002
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 11, 2011
    Manufacturer
    CONFORMIS
    Product Code
    NPJ
    PMA / PMN Number
    K093513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OCCURRED FOR PATIENT WITH A BICOMPARTMENTAL KNEE IMPLANT. THE PATIENT WAS REVISED DUE TO SYNOVIAL DISEASE AND GOUT INDICATIONS. THE IDUO G2 IMPLANT WAS LOOSENED DUE TO BONE DETERIORATION. THE COMPLAINT APPEARS TO BE PATIENT CONDITION RELATED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED FOR PATIENT WITH A BICOMPARTMENTAL KNEE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDUO G2 BICOMPARTMENTAL KNEE REPAIR SYSTEM NPJ CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R