BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 12032386 · Received June 21, 2021

    Report

    Report Number
    1220246-2021-03293
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 21, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    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

    IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN ADVERSE EVENT UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE. CONCOMITANT MEDICATION WAS USED TO TREAT THE ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934090 UNK TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other