BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE TRUNION,47 MM TPS CTD

    MDR report key: 11800267 · Received May 10, 2021

    Report

    Report Number
    1220246-2021-03048
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 10, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 AN ECLIPSE TOTAL SHOULDER CASE NEEDED A REVISION DUE TO A FAILED RCR. THERE WAS NO REPORT OF AN EVENT THAT CAUSED THE FAILURE. THE CALLER DID NOT KNOW THE ORIGINAL DATE OF SURGERY (STATED ONLY THAT IT WAS 'YEARS AGO'). THE PATIENT IS MALE, (B)(6) YEARS OLD. THE DEVICES FROM THE ORIGINAL CASE WERE REMOVED; THESE WERE REPLACED WITH AR-9502F-39CPC, AR-9501-10P, AR-9503M-03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697729 ECLIPSE TRUNION,47 MM TPS CTD TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE TRUNION,47 MM TPS CTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other