BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI GLENOID-PERIPHERAL LOCK SCRW

    MDR report key: 19837700 · Received July 26, 2024

    Report

    Report Number
    1220246-2024-06929
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 10, 2024
    Report Date
    February 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057739
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 PHOTOGRAPH PROVIDED BY THE CUSTOMER, WHICH SHOWS THE POLYETHYLENE BASE BROKEN IN HALF. THE METALLOSIS OBSERVED MAY BE A CONSEQUENCE OF THE DEVICE BREAKING DUE TO AN ACTIVE LIFESTYLE AND PHYSICAL WORK, AND THE POSSIBILITY THAT THE METAL WAS MAKING CONTACT DUE TO THE ABSENCE OF THE POLYETHYLENE BASE IN BETWEEN. CONSIDERING THE IMPLANTATION SURGERY WAS IN (B)(6) 2020, AND THE REPORTED EVENT OCCURRED ON (B)(6) 2024, THIS WEAR IS UNDERSTANDABLE AFTER 4 YEARS OF AN ACTIVE LIFESTYLE AND PHYSICAL WORK. THE DIRECTIONS FOR USE (DFU) FOR ECLIPSE SHOULDER PROSTHESIS, 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 (SEE BELOW). 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 BREAK OF THE POLYETHYLENE BASE DUE TO AN ACTIVE LIFESTYLE AND/OR PHYSICAL WORK AND THE PASSAGE OF 4 YEARS SINCE THE IMPLANTATION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A METALLOSIS. THE IMPLANT WAS IMPLANTED FOUR YEARS AGO WITH BONE GRAFT AUGMENTATION.. NO FURTHER INFORMATION WAS PROVIDED. UPDATE DW 12-JUL-2024: FURTHER INFORMATION WERE PROVIDED THAT DURING AN INITIAL SURGERY ON (B)(6) 2020 THE FOLLOWING DEVICES WERE IMPLANTED DUE TO AN OMARTHROSIS WITH B2 GLENOID SITUATION WITH A RETRO OF JUST UNDER 30 DEGREES . AR-9120-03, AR-9165-25NL, AR-9145-36, AR-9121-03, AR-9300-45CPC, AR-9301-04. ON (B)(6) 2024 THE REVISION SURGERY WAS PERFORMED. AS PART OF THE REVISION THE ECLIPSE AND UNIVERSAL GLENOID WERE ALL REMOVED DUE TO A SEVERE METALLOSIS. THE SURGEON DECIDED TO FIRST BUILD UP THE GLENOID WITH ALLOGRAFT IN A TWO-SIDED PROCEDURE AND TO INSERT A CEMENT SPACER ON THE HUMERUS SIDE. IN THE SECOND STEP - A UNIVERS REVERSE WILL BE INSERTED IN AUTUMN WITH PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922553 UNI GLENOID-PERIPHERAL LOCK SCRW SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW UNK 00888867057739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other