BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 24673831 · Received March 24, 2026

    Report

    Report Number
    1220246-2026-01620
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    ON 04-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT A REVISION FROM ECLIPSE + VAULTLOCK TSA TO RTSA ON (B)(6) 2026. THE PATIENT¿S ORIGINAL SURGERY DATE WAS (B)(6) 2024. THE REVISION WAS PERFORMED DUE TO SUBSCAPULARIS FAILURE AND NOT DUE TO FAILURE OF THE ECLIPSE OR VAULTLOCK IMPLANTS. HOWEVER, SIGNIFICANT VAULTLOCK EROSION WAS NOTED AT LESS THAN TWO YEARS POST-IMPLANTATION. THE ARTHREX IMPLANTS EXPLANTED DURING THE REVISION INCLUDED: AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, SMALL, AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM), AR-9301-39CPC ARTHREX ECLIPSE TRUNION 39 MM, SLOTTED, TPS CAP, AND AN AR-9339-18 ARTHREX ECLIPSE HUMERAL HEAD, 39/18. ADDITIONAL INFORMATION WAS RECEIVED ON 10-MAR-2026: THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2024 FOR A SUBSCAPULARIS TEAR SUSTAINED DURING A PHYSICAL ALTERCATION. DURING THE REVISION, ANTERIOR EROSION MEASURING APPROXIMATELY 2¿3 MM WAS OBSERVED. THE SURGEON DID NOT COMMENT ON WHETHER THE EROSION CONTRIBUTED TO THE NEED FOR REVISION OR IF IT WAS AN INCIDENTAL FINDING. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REPORTED. NO FURTHER SURGERIES ARE ANTICIPATED. THE PATIENT WAS DESCRIBED AS STABLE IMMEDIATELY FOLLOWING THE REVISION PROCEDURE; POSTOPERATIVE STATUS BEYOND LEAVING THE ROOM IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 16-MAR-2026: THE ARTHREX IMPLANT AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM WAS EXPLANTED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738360 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15181423 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other