BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE CAGE SCREW L, 40MM

    MDR report key: 11841617 · Received May 18, 2021

    Report

    Report Number
    1220246-2021-03097
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    December 9, 2020
    Report Date
    June 22, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867059948
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, NO ABNORMALITY WAS OBSERVED ON THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEGGED GLENOID GOT LOOSE AFTER SEVEN YEARS. A REVISION SURGERY WILL BE NECESSARY. UPDATE SWIT 23-DEC-2020: INITIAL SURGERY TOOK PLACE ON (B)(6) 2013. SURGERY REPORT INDICATION: PATIENT HAT PAIN IN THE RIGHT SHOULDER FOR ABOUT THREE TO FOUR YEARS WITH ONLY SOME LIMITED MOVEMENT. THE APRON GRIP IN PARTICULAR IS INCREASINGLY LIMITED. THE EXAMINATIONS INCLUDING AN ARTHRO MRI FROM (B)(6) 2012 REVEALED A PRONOUNCED OMARTHROSIS WITH A SLAP LESION AT A HIGH LEVEL. THE HUMERAL HEAD IS PROGRESSIVELY SUBLUXATING DORSALLY. THE INDICATION FOR SHOULDER ARTHROPLASTY IS CLEAR. REVISION SURGERY TOOK PLACE ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741816 ECLIPSE CAGE SCREW L, 40MM TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW L, 40MM 1009701 00888867059948

    Patients

    Seq Age Sex Outcome Treatment
    1 Other