BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GLENOID - INLAY LARGE

    MDR report key: 11075959 · Received December 28, 2020

    Report

    Report Number
    1220246-2020-02435
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 10, 2020
    Report Date
    September 2, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057432
    PMA / PMN Number
    K182039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED AS THE DEVICE WAS EXPLANTED AND RETURNED. SLIGHT DAMAGE WAS OBSERVED ON THE LOCKING PEGS BUT THE CAUSE OF THE EVENT IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED AS THE DEVICE WAS EXPLANTED AND RETURNED. SLIGHT DAMAGE WAS OBSERVED ON THE LOCKING PEGS BUT THE CAUSE OF THE EVENT IS UNDETERMINED.

    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 THAT THE PATIENT NEEDED TO HAVE A REVISION ON HIS SHOULDER. ORIGINAL DOS (B)(6) 2019 FOR A TOTAL SHOULDER. PER THE PATIENT, HE WAS SWATTING A FLY AND THE PLASTIC PIECE OF THE GLENOID DETACHED IN HIS SHOULDER. THE REVISION CASE WAS (B)(6) 2020. AN AR-9121-03 AND THE STEM (UNKNOWN PART #) WERE REMOVED. THE CASE WAS CONVERTED TO A REVERSE SHOULDER, A 42 GLENOPSHERE AND CUP WERE IMPLANTED. PATIENT IS MALE, (B)(6) YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542937 UNIVERSAL GLENOID - INLAY LARGE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE 17.00592 00888867057432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other