BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP

    MDR report key: 11912022 · Received June 1, 2021

    Report

    Report Number
    1220246-2021-03183
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 1, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867276161
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 THAT THE AR-9301-03 AND AR-9301-47CPC WERE IMPLANTED FOR A TOTAL SHOULDER CASE; PATIENT IS FEMALE, 60S. AFTER THE IMPLANT, THE SURGEON WAS CHECKING THE FIT; IT WAS LOOSE AND BOTH DEVICES PULLED OUT OF THE PATIENT WITH BONE MATTER ATTACHED TO IT. THEY CONVERTED THE CASE TO APEX AND IT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807698 ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP 19.04110 00888867276161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other