BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 3955160 · Received July 18, 2014

    Report

    Report Number
    3004153240-2014-00093
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 25, 2014
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K092441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OCCURRED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT. REVIEW FO THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE TIBIAL IMPLANTS WERE RETURNED AND INVESTIGATION IS IN PROGRESS. EVALUATION OF RETURNED IMPLANTS WILL BE DOCUMENTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423231 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention