BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED II LOCKING SCREW 1

    MDR report key: 21772204 · Received April 4, 2025

    Report

    Report Number
    0001649390-2025-00211
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    February 18, 2024
    Report Date
    June 12, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: 1. PRODUCT LONG DESCRIPTION (D1) OF SCREWS FROM AEQUALIS PERFORM REVERSED TO AEQUALIS REVERSED II. 2. MANUFACTURER ENTITY (D3) WAS UPDATED FROM TORNIER INC. TO TORNIER SAS. 3. FDA REGISTRATION NUMBER NEEDS TO BE UPDATED FROM 0001649390 - (B)(4) TO 3000931034 - (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT ONE PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, GLENOID IMPLANT WEAR AND DISLOCATION/SUBLUXATION 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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, GLENOID IMPLANT WEAR AND DISLOCATION/SUBLUXATION, 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    THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 FEBRUARY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, GLENOID IMPLANT WEAR AND DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633358 AEQUALIS REVERSED II LOCKING SCREW 1 SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention