BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 12706159 · Received October 27, 2021

    Report

    Report Number
    1220246-2021-03858
    Event Type
    Death
    Date Received
    October 27, 2021
    Date of Event
    September 28, 2021
    Report Date
    January 28, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING DONE TO CONFIRM THAT THE REPORTED EVENT WAS NOT CAUSED BY AN ARTHREX DEVICE. THIS EVENT WAS INITIALLY INDICATED AS PROBABLY NOT RELATED TO THE IMPLANTED DEVICE AND THE SURGEON CONFIRMED THAT THE PATIENT PASSED AFTER THE SURGERY HAD BEEN SUCCESSFULLY COMPLETED AND HAD NO RELATION TO THE ARTHROPLASTY PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED THAT RESULTED IN THE DEATH OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. THIS EVENT WAS INITIALLY INDICATED AS PROBABLY NOT RELATED TO THE IMPLANTED DEVICE AND THE SURGEON CONFIRMED THAT THE PATIENT PASSED AFTER THE SURGERY HAD BEEN SUCCESSFULLY COMPLETED AND HAD NO RELATION TO THE ARTHROPLASTY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603066 UNK PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death