BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ECLIPSE HUMERAL HEAD, 49/18

    MDR report key: 10333402 · Received July 28, 2020

    Report

    Report Number
    1220246-2020-01981
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867060067
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, NO ABNORMALITY WAS FOUND ON THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE CAUSE IS UNDETERMINED.

    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 UNDERWENT A TOTAL SHOULDER ARTHROPLASTY USING THE ECLIPSE SYSTEM ON (B)(6) 2020. UPON REVIEW OF THE POST OPERATIVE X-RAY, ON POST-OP DAY 1, IT WAS NOTICED THAT THE SHOULDER WAS DISLOCATED. A SECOND X-RAY WAS PERFORMED THE SAME DAY AND IT WAS CONFIRMED THAT THE SHOULDER WAS IN FACT DISLOCATED. THE PATIENT WAS NOT ABLE TO REMEMBER WHEN OR HOW THE SHOULDER MAY HAVE DISLOCATED. A REVISION TSA-HUMERAL HEAD EXCHANGE SURGERY WAS SCHEDULED AND PERFORMED ON (B)(6) 2020 (POST-OP DAY 1). IT WAS NOTED DURING THE REVISION THAT THE SUBSCAPULARIS REPAIR WAS STILL IN TACT BUT HAD TO BE TAKEN DOWN TO GET THE SHOULDER RELOCATED. AFTER THE SHOULDER WAS RELOCATED THE ECLIPSE HUMERAL HEAD, AR-9349-18 (LOT 18.0147) WAS REMOVED AND THE ENTIRE SHOULDER JOINT WAS EVALUATED FOR ANY POSSIBLE PROBLEM. THE SURGEON THEN PROCEEDED TO TRIAL THREE DIFFERENT HUMERAL HEAD SIZES AND SETTLED ON THE MOST STABLE HUMERAL HEAD WHICH WAS AN AR-9349-20 (LOT 1735002). A SPEEDBRIDGE TECHNIQUE WAS PERFORMED TO REPAIR THE SUBSCAPULARIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795145 ARTHREX ECLIPSE HUMERAL HEAD, 49/18 TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 49/18 18.01427 00888867060067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other