BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE TRUNION,41 MM TPS CTD

    MDR report key: 9409937 · Received December 4, 2019

    Report

    Report Number
    1220246-2019-01456
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 14, 2019
    Report Date
    February 11, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, NO ABNORMALITY WAS OBSERVED THAT MAY HAVE CONTRIBUTED TO THE ALLEGATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD AN ECLIPSE SURGERY ON THE (B)(6) 2016. FOR A WHILE EVERYTHING WAS FINE AND NO COMPLAINTS, BUT THEN ALL OF A SUDDEN SHE FELT PAIN. THE SURGEON DECIDED ON A REVISION SURGERY WHERE THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9105-01, AR-9341-16 (1295154707), AR-9300-41CPC (14.641), AR-9301-01 (13.225). A NEW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207216 ECLIPSE TRUNION,41 MM TPS CTD TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE TRUNION,41 MM TPS CTD 14.641

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other