BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQ REV II GLENOID BASEPLATE DIA 25MM

    MDR report key: 18386859 · Received December 22, 2023

    Report

    Report Number
    3000931034-2023-00473
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    April 28, 2021
    Report Date
    December 21, 2023
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S UNDER 510K K131231. BASED ON THE AVAILABLE INFORMATION THE DEVICE REMAINS IMPLANTED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A STUDY THAT THE PATIENT HAD A POSSIBLE STRESS FRACTURE. THE PATIENT STARTED HAVING PAIN OVER THE TOP OF THEIR RIGHT SHOULDER. STATES THAT IT IS QUITE IRRITATING AND HURTS WHENEVER SHE MOVES HER SHOULDER. PATIENT WILL HAVE A CT SCAN AND A SLING FOR THEIR RIGHT SHOULDER. RECOMMENDED PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299079 AEQ REV II GLENOID BASEPLATE DIA 25MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other