BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST

    MDR report key: 22792976 · Received August 13, 2025

    Report

    Report Number
    1220246-2025-03454
    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
    00888867352117
    PMA / PMN Number
    K211074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. VISUAL EVALUATION OF THE CUSTOMER-PROVIDED X-RAY IMAGES NOTED AN AR-9580-2420-2S. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    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
    76641 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. 24MM BASEPLATE, 20° FULL AUG, +2 LAT, ST 1426272301 00888867352117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other