BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 3143039 · Received May 23, 2013

    Report

    Report Number
    3004153240-2013-00082
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K111916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OCCURRED FOR PT WITH A UNICONDYLAR KNEE IMPLANT. PT WAS REVISED TO ANOTHER IMPLANT SYSTEM. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION SURGERY OCCURRED FOR PT WITH A UNICONDYLAR KNEE IMPLANT. PT WAS REVISED TO ANOTHER IMPLANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228086 IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM HSX CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention