BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GLENOID - INLAY LARGE

    MDR report key: 19579895 · Received June 21, 2024

    Report

    Report Number
    1220246-2024-06310
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    March 13, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057432
    PMA / PMN Number
    K182039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE AR-9121-03, UNIVERSAL GLENOID, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE DEVICE HAD NICKS ON THE EDGES AND DAMAGE ON THE PEG. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE DEVICE'S DIMENSIONS ARE CONGRUENT TO THE SPECIFICATIONS OF DRAWING C070137. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO EXCESSIVE USER-APPLIED MECHANICAL FORCES OVER TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 7/23/2024: THE INTENDED PROCEDURE WAS AN ANATOMIC SHOULDER WITH A UNIVERSAL CONVERTIBLE BASEPLATE BUT SINCE THE ARTHREX UNIVERSAL GLENOID WOULD NOT PRESS ONTO THE BASEPLATE, THE SURGEON COMPLETED THE CASE AS A REVERSE PROCEDURE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    ON 05/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9121-06 ARTHREX UNIVERSAL GLENOID AND TWO AR-9121-03 ARTHREX UNIVERSAL GLENOID WOULD NOT PRESS ONTO THE BASEPLATE. THE BASEPLATE WAS ALSO SWAPPED OUT AND ATTEMPTED WITH THE ARTHREX UNIVERSAL GLENOID, BUT IT STILL WOULD NOT HOLD. THE CASE WAS COMPLETED AS A REVERSE PROCEDURE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208885 UNIVERSAL GLENOID - INLAY LARGE SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE 22.03262 00888867057432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown