BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ECLIPSE HUMERAL HEAD, 47/18

    MDR report key: 14337532 · Received May 9, 2022

    Report

    Report Number
    1220246-2022-04889
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    October 11, 2021
    Report Date
    May 9, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867060043
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244344 ARTHREX ECLIPSE HUMERAL HEAD, 47/18 TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 47/18 1545001 00888867060043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other