BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE CAGE SCREW L, 40MM

    MDR report key: 19966876 · Received August 12, 2024

    Report

    Report Number
    1220246-2024-07155
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 22, 2024
    Report Date
    February 25, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    UDI-DI
    00888867059948
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE COMPLAINT IS CONFIRMED BASED ON THE X-RAY ((B)(4)) PROVIDED BY THE CUSTOMER, WHICH SHOWS THE HUMERAL HEAD MAKING DIRECT CONTACT WITH THE BASEPLATE, WITH NO POLYETHYLENE BASE IN BETWEEN. THE CONSTANT RUBBING OF BOTH METALS CAN CONTRIBUTE TO METALLOSIS. THE ABSENCE OF THE POLYETHYLENE BASE MAY BE A CONSEQUENCE OF DEVICE WEAR DUE TO AN ACTIVE LIFESTYLE. CONSIDERING THE IMPLANTATION SURGERY WAS IN (B)(6) 2007, AND THE REPORTED EVENT OCCURRED ON (B)(6) 2024, THIS WEAR IS UNDERSTANDABLE AFTER 17 YEARS. THE DIRECTIONS FOR USE (DFU) FOR ECLIPSE SHOULDER PROTHESIS, SECTION C. CONTRAINDICATIONS. 1. INSUFFICIENT QUANTITIES OR QUALITY OF HUMERAL HEAD AND/OR HUMERAL NECK BONE STOCK. 5. METAL ALLERGY. D. ADVERSE EFFECTS. 2. ALLERGIES AND OTHER REACTIONS TO DEVICE MATERIALS. 3. LOOSENING OF THE IMPLANT AS A RESULT OF CHANGED CONDITIONS IN LOAD TRANSFER, RESPECTIVELY, FATIGUE WEAR, OR TISSUE REACTION TO THE IMPLANT. LOOSENING IS FREQUENTLY A CONSEQUENCE OF ONE OR SEVERAL OF THE ABOVE LISTED RISK CONDITIONS BUT CAN ALSO BE CAUSED BY INADEQUATE ANCHORING TECHNIQUE. E. WARNINGS. 17. AN ARTIFICIAL JOINT IS SUBJECT TO WEAR AND/OR CAN LOOSEN OVER A PERIOD OF TIME. WEAR AND LOOSENING MAY MAKE IT NECESSARY TO RE-OPERATE ON AN ARTIFICIAL JOINT. H. FACTORS AND RISKS IMPACTING THE SAFETY AND SERVICE LIFE OF THE IMPLANT. 1. PATIENT WEIGHT. AN OVERWEIGHT PATIENT MAY PRESENT ADDITIONAL RISK. 2. EXTREME STRESS OR STRAIN RESULTING FROM WORK OR SPORT-RELATED ACTIVITY. 6. DEFORMATION OF THE OPERATIVE SITE, WHICH CAN PREVENT OR IMPEDE ANCHORING OF THE IMPLANT. 8. ALLERGIC REACTIONS TO IMPLANT MATERIALS. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE REPORTED FAILURE MAY BE A PATIENT-SPECIFIC EVENT, SPECIFICALLY THE WEAR OF THE POLYETHYLENE BASE DUE TO AN ACTIVE LIFESTYLE AND/OR THE PASSAGE OF 17 YEARS SINCE THE IMPLANTATION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON PICTURES IT WAS FOUND THAT AFTER AN IMPLANTATION IN (B)(6) 2007 THE COATING OF THE PAN IS ABRADED AND A METALLOSIS IS SUSPECTED. NO INFORMATION PROVIDED BY THE CUSTOMER. ***UPDATE DW 01-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE PROSTHESIS WAS IMPLANTED IN AGATHARIED FROM (B)(6) IN (B)(6) 2007. 3 YEARS AGO, THE PROSTHESIS STARTED TO MAKING NOISES IN SPECIFIC MOVEMENTS. (B)(6) HAS DIAGNOSED A WEAR OF THE POLY WITH A METALLOSIS AND OSTEOLYSEN. THE SURGEON ADVISED THE PATIENT TO CLARIFY THE EVENT WITH AN ADDITIONAL ARTHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514474 ECLIPSE CAGE SCREW L, 40MM TOT ANAT SHOULDR PROSTH, UNCEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW L, 40MM 0717003 00888867059948

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other