BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOID SPHERE

    MDR report key: 6078340 · Received November 4, 2016

    Report

    Report Number
    3000931034-2016-00189
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    REVISION SURGERY AT 19 MONTHS POST-OPERATIVE DUE TO LOOSENING OF THE BASEPLATE LEADING TO INSERT WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729711 AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOID SPHERE SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other