BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS HUMERAL HEAD

    MDR report key: 6202007 · Received December 23, 2016

    Report

    Report Number
    3000931034-2016-00229
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 2, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386915574
    PMA / PMN Number
    K012212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 THE PATIENT UNDERWENT REVISION SURGERY AT 6 YEARS POST-OPERATIVE DUE TO LOOSENING/LYSIS. THE IMPLANTED HUMERAL COMPONENTS AND ANOTHER MANUFACTURER'S GLENOID COMPONENT WERE REMOVED. CONVERSION INTO RSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852245 AEQUALIS HUMERAL HEAD SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S. 52X19 03700386915574

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other