BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 1972212 · Received January 18, 2011

    Report

    Report Number
    3004153240-2011-00006
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 28, 2010
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K092441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION. INTERVENTION PLANNED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    PT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION. INTERVENTION PLANNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R