BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL GLENOID - INLAY LARGE

    MDR report key: 8566432 · Received April 30, 2019

    Report

    Report Number
    1220246-2019-01063
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    July 4, 2018
    Report Date
    April 30, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057432
    PMA / PMN Number
    K182039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS REQUESTED BUT 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 BY THE PATIENT THAT HE HAD A SHOULDER SURGERY ON (B)(6) 2014. HE EXPERIENCED A TRAUMA ON (B)(6) 2018. HE FELL ON AN ICE PLATE IN WINTER. ON (B)(6) 2018 IT WAS NOTICED THAT THE PE-INLAY IMPLANT BROKE. THE IMPLANT WAS REMOVED ON (B)(6) 2018. A NEW IMPLANT WAS IMPLANTED ON (B)(6) 2018. NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE. WE DO NOT HAVE ANY INFORMATION ON PART NUMBER / IF IT IS AN ARTHREX DEVICE / WHICH CUSTOMER WAS THE OPERATING HOSPITAL ETC. ARTHREX IS STILL WORKING ON RECEIVING FURTHER INFORMATION SO THIS INCIDENT CAN BE EVALUATED. UPDATE 08-APR-19: FOLLOWING DEVICES WERE IMPLANTED ON INITIAL SURGERY: AR-9349-20 (LOT.: 1295124702), AR-9301-02 (LOT.: 2501338911), AR-9121-03 (LOT.: 1031003), AR-9300-49CPC (2501321807). ONLY AR-9121-03 BROKE. UPDATE 09-APR-19: IT WAS ALSO MENTIONED THAT DUE TO PAIN IN THE LEFT SHOULDER AN ARTHROSCOPY IN THE LEFT SHOULDER TOOK PLACE FOR CONTROL. IT WAS NOT POSSIBLE FOR THE CUSTOMER TO TELL US IF THOSE IMPLANTS WERE ARTHREX DEVICES. NO PART NUMBERS OR LOT NUMBERS AVAILABLE. BUT THE SURGEON CONFIRMED THAT THERE WAS NOTHING WRONG WITH THE IMPLANT IN THE LEFT SHOULDER. HE CANT PROVIDE US THE INFORMATION WHERE THE PAIN IN THE PATIENTS LEFT SHOULDER COMES FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360875 UNIVERSAL GLENOID - INLAY LARGE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE 1031003 00888867057432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other