BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE

    MDR report key: 20349589 · Received October 2, 2024

    Report

    Report Number
    3000931034-2024-00593
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    January 1, 2017
    Report Date
    October 2, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    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 (DWE870) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K140478. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED 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 IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6). INFECTION. PATIENT REQUIRED IRRIGATION AND DEBRIDEMENT ALONG WITH ANTIBIOTICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915484 AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention