BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE

    MDR report key: 11437148 · Received March 8, 2021

    Report

    Report Number
    1220246-2021-02694
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 17, 2021
    Report Date
    March 9, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867250703
    PMA / PMN Number
    K161108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE CENTRAL PEG BROKE OFF FLUSH WITH THE REST OF THE DEVICE. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER A LIKELY CAUSE IS USER-APPLIED MECHANICAL FORCES.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN APEX TOTAL SHOULDER REPAIR THE AR-9236-04PP CENTER PEG BROKE WHEN TRYING TO REMOVE. ALL PIECES WERE RETRIEVED WITH NO ISSUES TO CASE. AR-9231-20 WAS NOT WORKING ON BROACH AND VERSION ROD ANGLES WERE OFF. THESE ITEMS WERE REPLACED AND THE CASE WAS COMPLETED AND THE PATIENT IS FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338233 UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE 1027261635 00888867250703

    Patients

    Seq Age Sex Outcome Treatment
    1