BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED PROSTHESIS

    MDR report key: 7822344 · Received August 28, 2018

    Report

    Report Number
    3000931034-2018-00112
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 7, 2018
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K081059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE SOURCE OF THIS REPORT LITERATURE : "REVERSE SHOULDER ARTHROPLASTY WITH A NEW CONVERTIBLE SHORT STEM: PRELIMINARY 2- TO 4-YEAR FOLLOW-UP RESULTS" ASCIONE F. ET AL., J SHOULDER ELBOW ARTHROPLASTY, 2017.

    Description of Event or Problem · 1

    FROM LITERATURE : "REVERSE SHOULDER ARTHROPLASTY WITH A NEW CONVERTIBLE SHORT STEM: PRELIMINARY 2- TO 4-YEAR FOLLOW-UP RESULTS" ASCIONE F. ET AL., J SHOULDER ELBOW ARTHROPLASTY, 2017. FOUR IMPLANTS REQUIRED REVISION: 3 SINGLE STAGE REVISIONS FOR INFECTIONS, 1 CHANGE TO THICKER PE INSERT-HUMERAL TRAY COMPLEX AND LARGER GLENOSPHERE FOR INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663463 AEQUALIS REVERSED PROSTHESIS SHOULDER PROSTHESIS KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other