BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM

    MDR report key: 22665697 · Received July 30, 2025

    Report

    Report Number
    1220246-2025-03150
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 2, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSD
    UDI-DI
    00888867439092
    PMA / PMN Number
    K230366
    Product Problem
    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: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD INFORMATION, ARTHREX WAS ABLE TO DETERMINE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING INCORRECT SURGICAL TECHNIQUE DURING DEVICE APPLICATION. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

    Description of Event or Problem · 0

    ON 07/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9501-04-135P UNIVERS REVERS MONOBLOCK WAS LOOSE AND MISMATCHED IN SIZE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513953 UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM SHOULDR PROSTH, REVERSE CONFIG HSD ARTHREX, INC. UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM 23.01781 00888867439092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown