BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IUNI G2

    MDR report key: 3854894 · Received May 28, 2014

    Report

    Report Number
    3004153240-2014-00066
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CONFORMIS
    Product Code
    HSX
    PMA / PMN Number
    K111916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OF THE TIBIAL IMPLANTS IS PLANNED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT. REASON FOR REVISION IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    REVISION SURGERY OF THE TIBIAL IMPLANTS IS PLANNED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT. REASON FOR REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315102 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention