BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ECLIPSE HUMERAL HEAD, 49/18

    MDR report key: 23935634 · Received December 31, 2025

    Report

    Report Number
    1220246-2025-05937
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 10, 2025
    Report Date
    April 16, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867060067
    PMA / PMN Number
    K183194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. PER SURGICAL TECHNIQUE - ECLIPSE¿ TOTAL SHOULDER ARTHROPLASTY SYSTEM - PAG 10 - NOTE: DO NOT OVERTIGHTEN THE SCREW, AS THIS COULD LEAD TO INEFFECTIVE FIXATION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR WITH THE DEVICE DUE TO IMPROPER SURGICAL TECHNIQUE DURING THE TIGHTENING/OVERTIGHTEN THE ECLIPSE WITH THE SCREW. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OBJECTIVE EVIDENCE (E.G., DEVICE ANALYSIS, PHOTOGRAPHS, OR SUPPORTING DOCUMENTATION) WAS AVAILABLE TO CONFIRM A DEVICE-RELATED FAILURE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9349-18 ARTHREX ECLIPSE HUMERAL HEAD WAS NOT ENGAGING PROPERLY WITH THE TRUNNION. THE REPORTER CONFIRMED THAT THE CAGE SCREW WAS FULLY SEATED WITHIN THE TRUNNION. THE TEAM ATTEMPTED TO REMOVE AND RE-IMPLANT THE COMPONENT; HOWEVER, THE ECLIPSE HEAD STILL WOULD NOT SEAT CORRECTLY. A NEW ECLIPSE HEAD WAS OPENED AND IMPLANTED WITHOUT ISSUE, ALLOWING THE PROCEDURE TO PROCEED AS PLANNED. THIS WAS DISCOVERED DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 16-DEC-2025: THE ISSUE WAS IDENTIFIED DURING USE INSIDE THE PATIENT. NO FRAGMENTS BROKE AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT ECLIPSE HUMERAL HEAD, AR-9349-20, 49/20, WITH THE ORIGINAL TRUNNION. THERE WAS NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536829 ARTHREX ECLIPSE HUMERAL HEAD, 49/18 TOT ANAT SHOULDR PROSTH, UNCEM QHQ ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 49/18 244145 00888867060067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown