BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOSPHERE

    MDR report key: 6180950 · Received December 16, 2016

    Report

    Report Number
    3000931034-2016-00219
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    September 4, 2015
    Report Date
    November 18, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    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 A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832701 AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOSPHERE SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other