BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS PERFORM GLENOID

    MDR report key: 6025999 · Received October 13, 2016

    Report

    Report Number
    3000931034-2016-00150
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386937330
    PMA / PMN Number
    K111902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 9 MONTHS POST-OPERATIVE DUE TO ROTATOR CUFF TEAR AND LOOSENING OF THE STEM. THE IMPLANTED STEM, HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. CONVERSION INTO RSA. SURGEON'S COMMENT: HE SHOULD HAVE DONE RSA INSTEAD OF TSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676703 AEQUALIS PERFORM GLENOID SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S. PEGGED S30 03700386937330

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other