BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IUNI G2

    MDR report key: 3881469 · Received February 19, 2014

    Report

    Report Number
    3004153240-2014-00018
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    July 1, 2013
    Report Date
    July 9, 2013
    Manufacturer
    CONFORMISS
    Product Code
    HSX
    PMA / PMN Number
    K092441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDLE BROKE OFF THE DISPOSABLE TRIAL TIBIAL INSERT COMPONENT AS THE TRIAL WAS BEING REMOVED FROM THE JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE HANDLE BROKE OFF THE DISPOSABLE TRIAL TIBIAL INSERT COMPONENT AS THE TRIAL WAS BEING REMOVED FORM THE JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104214 IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM HSX CONFORMISS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR