BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

    MDR report key: 16779153 · Received April 20, 2023

    Report

    Report Number
    3000931034-2023-00102
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    November 11, 2010
    Report Date
    April 20, 2023
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 ON A SUPPLEMENTAL REPORT. THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE CLEARED 510K K131231. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY OF THE COMPLETE HUMERAL AND GLENOID SIDES DUE TO CALCIFIC PSEUDOTUMOR. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624740 AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention