BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 2833141 · Received November 7, 2012

    Report

    Report Number
    3004153240-2012-00099
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    FORMISCONFORMIS, INC.
    Product Code
    HSX
    PMA / PMN Number
    K092441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS 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. REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM HSX FORMISCONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R