BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLS UNI EVOLUTION

    MDR report key: 6042816 · Received October 20, 2016

    Report

    Report Number
    3000931034-2016-00177
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    December 8, 2014
    Report Date
    September 20, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HSX
    PMA / PMN Number
    K022211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO TIBIAL FRACTURE AT 6 MONTHS POST-OP. NO ADDITIONAL DETAILS WERE PROVIDED. CONVERSION TO A TOTAL KNEE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694268 HLS UNI EVOLUTION UNICOMPARTIMENTAL KNEE PROSTHESIS HSX TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other