BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 3021060 · Received March 13, 2013

    Report

    Report Number
    3004153240-2013-00043
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HSX
    PMA / PMN Number
    K111916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY IS PLANNED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT DUE TO PRESENCE OF OSTEOARTHRITIS IN ON THE OPPOSITE CONDYLE OF THE TREATED KNEE. PATIENT WILL BE REVISED TO A TKA. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION SURGERY IS PLANNED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT DUE TO PRESENCE OF OSTEOARTHRITIS IN THE OPPOSITE CONDYLE OF THE TREATED KNEE. PATIENT WILL BE REVISED TO A TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106356 IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM HSX CONFORMIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR