BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ECLIPSE HUMERAL HEAD, 41/16

    MDR report key: 9473749 · Received December 16, 2019

    Report

    Report Number
    1220246-2019-01496
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 16, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867059986
    PMA / PMN Number
    K183914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT (FEMALE, (B)(6) YEARS), HAD AN ECLIPSE TOTAL SHOULDER ON (B)(6) 2016. DUE TO A SUBSEQUENT TORN ROTATOR CUFF, SHE NEEDED TO HAVE A REVERSE TOTAL SHOULDER ON (B)(6) 2019. REPORTER STATED THAT THE TORN ROTATOR CUFF WAS NOT DUE TO PRODUCT MALFUNCTION. REMOVED FROM THE PATIENT WAS AR-9341-16, AR-9300-41CPC AND AR-9301-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271722 ARTHREX ECLIPSE HUMERAL HEAD, 41/16 TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 41/16 1295122505 00888867059986

    Patients

    Seq Age Sex Outcome Treatment
    1