BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION HUMERAL INSERT 33+3 / 36

    MDR report key: 21559785 · Received March 10, 2025

    Report

    Report Number
    1220246-2025-00868
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    September 13, 2024
    Report Date
    September 2, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSD
    UDI-DI
    00888867406476
    PMA / PMN Number
    K221232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: D6B, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 2/11/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A BONE FRACTURE IN THE TARGETED SHOULDER. ABOUT SEVEN MONTHS POST OPERATION, THE PATIENT MADE A QUICK TURN AROUND AND ENDED UP FRACTURING THE GLENOID CAVITY OF RIGHT SCAPULA. THIS WAS CONFIRMED VIA A CT SCAN ON (B)(6)2024. THE PATIENTS PAIN BEGAN TO IMPROVE AS OF (B)(6)2024. THE PATIENT REPORTED DECREASED RANGE OF MOTION ON (B)(6)2024 AND SHARP PAIN ON (B)(6)2025. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6)2025. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS SYSTEM IMPLANTED ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 2/21/2025: DURING THE REVISION SURGERY ON (B)(6)2024, AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD, AN AR-9501-04-135R UNIVERS REVERS STEM, AN AR-9503-3336-3 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2436 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9580-2420-2S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE, AND AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986205 COMBINATION HUMERAL INSERT 33+3 / 36 SHOULDR PROSTH, REVERSE CONFIG HSD ARTHREX, INC. COMBINATION HUMERAL INSERT 33+3 / 36 23.01220 00888867406476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other