BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID, LARGE

    MDR report key: 23958212 · Received January 5, 2026

    Report

    Report Number
    1220246-2026-00050
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 15, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867239333
    PMA / PMN Number
    K161108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    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 RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR, INCLUDING EXCESSIVE FORCE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.

    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 16-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9106-03 VAULT LOCK GLENOID TRIAL BOTTOM PEG BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO CASE. ALL FRAGMENTS WERE REMOVED AND THE CASE COMPLETED USING ANOTHER GLENOID TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440005 UNIVERS VAULTLOCK GLENOID, LARGE PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, LARGE S81303051 00888867239333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown