BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 1770203 · Received July 21, 2010

    Report

    Report Number
    3004153240-2010-00020
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 25, 2010
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K092441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD INDICATED THAT DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    PATIENT WITH A UNICONDYLAR KNEE IMPLANT WAS HOSPITALIZED WITH A SUPERFICIAL INFECTION/CELLULITIS IN THE LEFT KNEE. PATIENT WAS TREATED WITH IV ANTIBIOTICS AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM HSX CONFORMIS M57220600210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization