BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE CAGE SCREW M, 35MM

    MDR report key: 19894762 · Received August 2, 2024

    Report

    Report Number
    1220246-2024-07011
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 10, 2024
    Report Date
    July 2, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H3, H6. ADDITIONAL INFORMATION RECEIVED ON 11/7/2024: THE PATIENT UNDERWENT REVISION TO AN RSA IMPLANT SYSTEM ON (B)(6) 2024.

    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. 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. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/7/2024: THE PATIENT UNDERWENT REVISION TO AN RSA IMPLANT SYSTEM ON (B)(6) 2024.

    Description of Event or Problem · 0

    ON 7/10/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY WILL UNDERGO RSA REVISION SURGERY DUE TO A SUBSCAPULARIS FAILURE. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE CLINIC WITH PAIN, AND IT WAS DETERMINED THAT DUE TO SUBSCAPULARIS FAILURE, THE PATIENT WILL UNDERGO REVISION SURGERY TO AN RSA IMPLANT SYSTEM. AN AR-9301-45CPC ARTHREX ECLIPSE TRUNION 45 MM, SLOTTED, TPS CAPWAS, AN AR-9345-17 ARTHREX ECLIPSE HUMERAL HEAD, 45/17, AN AR-9107-01-15R UNIVERSE VAULT LOCK AUGMENTED GLENOID, SMALL 15R, AND AN AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM) WERE IMPLANTED IN THE PATIENT ON (B)(6) 2023. THIS EVENT WAS INDICATED AS UNRELATED TO THE ECLIPSE IMPLANT SYSTEM, OR THE STUDY PATIENT WAS PART OF. THE REASON FOR THE SUBSCAPULARIS FAILURE IS UNKNOWN. NO INJURY THAT LED TO FAILURE. THE PATIENT IS STILL EXPERIENCING INSTABILITY, AND THE REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385117 ECLIPSE CAGE SCREW M, 35MM TOT ANAT SHOULDR PROSTH, UNCEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other