BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST

    MDR report key: 21093146 · Received January 7, 2025

    Report

    Report Number
    3000931034-2025-00009
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    December 11, 2024
    Report Date
    April 15, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 IS COMMERCIALLY AVAILABLE CLEARED UNDER 510K # K140478. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION - PLEASE REFER H6 CLINICAL CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    PATIENT RETURNED AFTER SOME MONTHS TO PRIMARY SURGEON COMPLAINING OF PAIN. CT SCAN SHOWED SPACE BETWEEN IMPLANT AND GLENOID BONE. DECISION MADE TO REVISE GLENOID COMPONENT. PRIMARY IMPLANTS REMOVED AND EXCHANGED FOR NEW PROSTHESIS FROM DIFFERENT PRODUCT LINE. REVISION SURGERY COMPLETED. PRIMARY SURGERY DATE: (B)(6) 2023. REVISION SURGERY DATE: (B)(6) 2024.

    Description of Event or Problem · 0

    PATIENT RETURNED AFTER SOME MONTHS TO PRIMARY SURGEON COMPLAINING OF PAIN. CT SCAN SHOWED SPACE BETWEEN IMPLANT AND GLENOID BONE. DECISION MADE TO REVISE GLENOID COMPONENT. PRIMARY IMPLANTS REMOVED AND EXCHANGED FOR NEW PROSTHESIS FROM DIFFERENT PRODUCT LINE. REVISION SURGERY COMPLETED. PRIMARY SURGERY DATE: (B)(6) 2023. REVISION SURGERY DATE: (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105610 AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. AG1026037

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention