BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM +4 LAT BASEPLATE, MODULAR

    MDR report key: 23759249 · Received December 9, 2025

    Report

    Report Number
    1220246-2025-05525
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296473
    PMA / PMN Number
    K173900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE CONNECTION BETWEEN THE BASE PLATE AND THE BOLT BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. FURTHER INFORMATION RECEIVED WITH A REGARDING CRM CASE: IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CONNECTION BETWEEN THE SCREW AND THE BASEPLATE IS BROKEN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553504 24MM +4 LAT BASEPLATE, MODULAR SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. 24MM +4 LAT BASEPLATE, MODULAR 15438205 00888867296473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown