BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED INSERT

    MDR report key: 9610280 · Received January 21, 2020

    Report

    Report Number
    3000931034-2019-00202
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    December 11, 2019
    Report Date
    December 23, 2019
    Product Code
    KWS
    UDI-DI
    03700386916540
    PMA / PMN Number
    K050316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    THIS PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSED ON (B)(6) 2019. AFTER THE SURGERY, THE GLENOID SPHERE FELL OUT FROM THE BASEPLATE, AND THE DISLOCATION OCCURRED. THERE WAS A REVISION SURGERY ON (B)(6) 2019. THE GLENOID SPHERE AND THE INSERT WERE NEWLY REPLACED TO THE IMPLANTS WITH THE SAME PRODUCT NUMBER. ALSO THE SPACER (DWB) WAS USED THIS TIME, AND THE SURGERY WAS COMPLETED. THE SURGEON COMMENTED "THE DISLOCATION MIGHT OCCUR BECAUSE MY TIGHTENING WAS TOO LOOSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76053 AEQUALIS REVERSED INSERT SHOULDER JOINT POLYMER PROSTHESIS KWS LATERALIZED 36X6MM AC4233 03700386916540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other