BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24979276 · Received April 24, 2026

    Report

    Report Number
    1220246-2026-02420
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    July 1, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    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.

    Description of Event or Problem · 0

    ON 02-APR-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2025 BY THE JOURNAL OF SHOULDER AND ELBOW SURGERY, TITLED ¿EFFECT OF LATERALIZATION AND DISTALIZATION ON TUBEROSITY HEALING AND FUNCTIONAL OUTCOMES AFTER REVERSE TOTAL SHOULDER ARTHROPLASTY WITH UNIVERS REVERS TOTAL SHOULDER SYSTEM FOR PROXIMAL HUMERUS FRACTURES: A RANDOMIZED CONTROLLED TRIAL COMPARING 135° AND 155° UNCEMENTED STEMS". THE STUDY REVIEWED ONE SEVENTY-SIX (76) PATIENTS WHO UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) TO ADDRESS ACUTE (<3 WEEKS) NEER 3- OR 4-PART PHF, HEAD SPLIT FRACTURE, OR A DISPLACED NEER 2-PART PHF WITH OSTEOPOROSIS AND/OR A ROTATOR CUFF TEAR, USING ARTHREX UNIVERSAL GLENOID DEVICES. DURING THE MINIMUM TWO (2) YEAR FOLLOW-UP PERIOD, ONE (1) PATIENT EXPERIENCED ACROMION FRACTURE/ACROMION STRESS FRACTURE. SOURCE: RIUS, X., GONZALEZ-MORGADO, D., MATELLANES, J., LUZARDO, A., AGULLO, J. L., & HACHEM, A. I. (2025). EFFECT OF LATERALIZATION AND DISTALIZATION ON TUBEROSITY HEALING AND FUNCTIONAL OUTCOMES AFTER REVERSE TOTAL SHOULDER ARTHROPLASTY WITH UNIVERS REVERS TOTAL SHOULDER SYSTEM FOR PROXIMAL HUMERUS FRACTURES: A RANDOMIZED CONTROLLED TRIAL COMPARING 135° AND 155° UNCEMENTED STEMS. JOURNAL OF SHOULDER AND ELBOW SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222460 UNK SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other