BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28MM +2 LAT BASEPLATE, MODULAR

    MDR report key: 19042471 · Received April 4, 2024

    Report

    Report Number
    1220246-2024-01813
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    October 5, 2021
    Report Date
    April 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296503
    PMA / PMN Number
    K173900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED, THE AR-9560-28-2 AND MATING AR-9561-35S DID NOT MATE. THE HEX FEATURES WERE FOUND TO BE DAMAGED, INDICATING THE DEVICES WERE ATTEMPTED TO BE ASSEMBLED WHILE THEY WERE NOT ALIGNED.

    Description of Event or Problem · 0

    ON 10/11/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS USING AN AR-9622 TAPER ASSEMBLY PRESS WAS USED TO PAIR THE AR-9560-28-2, 28MM +2 LAT. MGS BASEPLATE AND AR-9561-35S, 35MM CENTRAL SCREW, BUT UPON INSERTION THE BASEPLATE AND CENTRAL SCREW DISASSOCIATED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON 10/5/2021. THE CASE WAS COMPLETED BY REMOVING THE CENTRAL SCREW FROM THE GLENOID WITH REMOVAL DRIVER AND THEN OPENED NEW IMPLANTS WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335178 28MM +2 LAT BASEPLATE, MODULAR SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. 28MM +2 LAT BASEPLATE, MODULAR 11634848 00888867296503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown