BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5X24MM PERIPHERAL SCREW, LOCKING

    MDR report key: 22792984 · Received August 13, 2025

    Report

    Report Number
    1220246-2025-03456
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 24, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296848
    PMA / PMN Number
    K173900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. VISUAL EVALUATION OF THE CUSTOMER-PROVIDED X-RAY IMAGES NOTED AN AR-9563-24 UNIVERS REVERS¿ AUGMENTED MODULAR GLENOID SYSTEM. REFER TO ATTACHMENTS. BASED ON THE INFORMATION PROVIDED, ARTHREX WAS NOT ABLE TO CONFIRM THE ALLEGED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. REF: LT1-000169-EN-US UNIVERS REVERS¿ AUGMENTED MODULAR GLENOID SYSTEM SURGICAL TECHNIQUE.

    Description of Event or Problem · 0

    ON 07/25/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE AR-9580-2420-2S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE (24 MM) HAD FAILED, NECESSITATING A REVISION PROCEDURE. THE ISSUE ORIGINATED DURING A REVERSE SHOULDER ARTHROPLASTY PERFORMED ON (B)(6) 2025. TO ADDRESS THE FAILURE, THE SURGICAL TEAM SUCCESSFULLY REMOVED THE AR-9580-2420-2S BASEPLATE (24 MM), AR-9582-30 MODULAR POST FOR AUGMENTED MGS BASEPLATE 30 MM, AR-9563-24 PERIPHERAL LOCKING SCREW, AND AR-9563-36 PERIPHERAL LOCKING SCREW. THEY PROCEEDED WITH THE IMPLANTATION OF A NON-ARTHREX SMALL SCREW BASEPLATE, WHICH WAS SUPPLEMENTED BY BONE GRAFTING. A NEW ARTHREX CUP AND POLYETHYLENE LINER WERE ALSO PLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/31/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65432 5.5X24MM PERIPHERAL SCREW, LOCKING SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. 5.5X24MM PERIPHERAL SCREW, LOCKING 15246848 00888867296848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other