BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST

    MDR report key: 23958133 · Received January 5, 2026

    Report

    Report Number
    3000931034-2026-00012
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    April 17, 2025
    Report Date
    March 3, 2026
    Manufacturer
    TORNIER S.A.S.
    Product Code
    PHX
    UDI-DI
    03700386935817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWD171) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K131231. THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWD171) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K131231. THE REPORTED EVENT 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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    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 OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28196 AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER S.A.S. AD7676 03700386935817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention