BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS GLENOID KEELED

    MDR report key: 6147346 · Received December 6, 2016

    Report

    Report Number
    3000931034-2016-00204
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 9, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386915420
    PMA / PMN Number
    K060209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE WAS MANUFACTURED IN ACCORDANCE WITH OUR SPECIFICATIONS. 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 8.5 YEARS POST-OPERATIVE DUE TO GLENOID IMPLANT WEAR. CONVERSION TO RSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800340 AEQUALIS GLENOID KEELED SHOULDER JOINT POLYMER PROSTHESIS KWS TORNIER S.A.S. MEDIUM 9553AF026 03700386915420

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other