BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS

    MDR report key: 7230257 · Received January 31, 2018

    Report

    Report Number
    3000931034-2018-00005
    Event Type
    Injury
    Date Received
    January 31, 2018
    Report Date
    January 1, 2018
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT.

    Description of Event or Problem · 1

    "FAILURE OF THE TORNIER AEQUALIS TOTAL SHOULDER SYSTEM. LOOSENING OF THE COMPONENTS, CAUSING SEVERE PAIN IN THE SHOULDER AND SURROUNDING REGIONS, LACK OF MOBILITY, AND BONE AND TISSUE DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73699 AEQUALIS SHOULDER JOINT PROSTHESIS KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other