BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM

    MDR report key: 21823871 · Received April 11, 2025

    Report

    Report Number
    3000931034-2025-00192
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    August 8, 2019
    Report Date
    April 11, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWB945) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K030941. THE REPORTED EVENT THAT ONE PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE NATIONAL JOINT REGISTRY. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. PLEASE NOTE, THAT REPORTS RECEIVED FROM THE NATIONAL JOINT REGISTRY ARE NOT PUBLISHED REPORTS AND THEREFORE WEB LINK IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2013 ¿ (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019, A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007504 AEQUALIS REVERSED CEMENTLESS STEM HA D9MM L100MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 1774AT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention