BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE CAGE SCREW M, 35MM

    MDR report key: 18776698 · Received February 26, 2024

    Report

    Report Number
    1220246-2024-01113
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 6, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER. VISUAL EVALUATION REVEALED AN EXPLANTED AR-9301-02. IN ADDITION, A PHOTO OF THE METALLOSIS WAS ALSO PROVIDED. THE HEAD, TINBN, IS AN INFERIOR BEARING SURFACE THAN THE STANDARD COBALT CHROME. LIKELY DONE DUE TO THE PATIENT HAVING A NICKEL ALLERGY. THIS BEARING SURFACE MAY HAVE CONTRIBUTED TO WEARING THE POLY MORE QUICKLY. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF AN ECLIPSE WITH UNIVERSAL GLENOID WAS NECESSARY DUE TO WEAR OF THE POLYETHYLENE GLENOID OF THE UNIVERSAL GLENOID BASE PLATE. IT WAS FURTHER REPORTED THAT THE ISSUE CAUSE A STRONG METALLOSIS DUE TO THE METAL TO METAL FRICTION. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: CD-9341-16 ECLIPSE HEAD, SIZE 41/16 TINBN COATED. AR-9300-41CPC ECLIPSE TRUNION,41 MM TPS CTD. AR-9301-02 ECLIPSE CAGE SCREW M, 35MM. AR-9120-01 UNIVERSAL GLENOID - BASEPLATE SMALL. AR-9165-20 UNIVERSAL GLENOID - CENTRAL SCREW 20MM. 2X UNKNOWN PERIPHERAL SCREWS.

    Description of Event or Problem · 0

    *** UPDATE DW 08-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT THE DEVICES WERE INITIALLY IMPLANTED IN 2016. *** UPDATE DW 28-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310378 ECLIPSE CAGE SCREW M, 35MM TOT ANAT SHOULDR PROSTH, UNCEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM 13.226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other