BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GLENOID - INLAY LARGE PLUS

    MDR report key: 19579466 · Received June 20, 2024

    Report

    Report Number
    1220246-2024-06308
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    March 13, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057463
    PMA / PMN Number
    K182039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. TWO AR-9121-06, UNIVERSAL GLENOIDS, WERE RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE DEVICES HAD NICKS ON THE EDGES AND DAMAGE ON THE PEGS. FUNCTIONAL TESTING IS NOT POSSIBLE DUE TO THE DAMAGE OF THE GEOMETRY OF THE GLENOIDS. 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.

    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.

    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
    1577007 UNIVERSAL GLENOID - INLAY LARGE PLUS SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE PLUS 22.04745 00888867057463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown