BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

    MDR report key: 18833324 · Received March 4, 2024

    Report

    Report Number
    3000931034-2024-00074
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    October 1, 2021
    Report Date
    March 4, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K030941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWB960) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K030941. IT CANNOT BE DETERMINED WHICH, AND IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPONENT DISSOCIATION SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WILL BE MADE AVAILABLE BY 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. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN

    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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166436 AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. 9974AT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention