BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI GLENOID-PERIPHERAL LOCK SCRW

    MDR report key: 12814146 · Received November 15, 2021

    Report

    Report Number
    1220246-2021-03918
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    November 25, 2020
    Report Date
    November 15, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057722
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, NO ABNORMALITIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE DRIVE FEATURE DAMAGE IS LIKELY A RESULT OF THE IMPLANTATION AND/OR REMOVAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 YEARS AFTER THE INITIAL SURGERY IN THE (B)(6) A REVISION SURGERY OF THE ECLIPS WITH THE UNIVERSAL GLENOID WAS NECESSARY AS THE PATIENT SUFFERED PAIN IN THE SHOULDER JOINT. THE SUBSCAPULARIS NO LONGER HAD ANY FUNCTION. THEREFORE AN INVERSE PROSTHESIS WAS INDICATED AND A PROTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. AS THE PATIENT WAS ALLERGIC TO METAL NO MODULAR CONVERSION OF THE GLENOID COULD BE PERFORMED. THEREFORE THE UNIVERSAL GLENOID AND THE ECLIPSE HAD TO BE REMOVED. THE SURGEON FURTHER REPORTED THAT DARK TRACES WERE IDENTIFIED BELOW THE TRUNNION. THESES LYSIS FRINGES ARE THE RESULT OF THE PE ABRASION. ONLY SMALL FRAGMENTS OF THE PE INSERT WERE STILL PRESENT. UPDATE 22-FEB-2021 DW. X-RAY PICTURES AND A SURGERY REPORT WAS PROVIDED WITH THE INFORMATION THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017. THE REPORTED EVENT WAS IDENTIFIED ON (B)(6) 2020 VIA SCINTIGRAPHY. UPDATE 26-FEB-2021 DW. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. UPDATE 01-SEP-2021 DW. ADDITIONAL DEVICES WERE RETURNED AND ADDED TO THE CASE. UPDATE 25-OCT-2021 DW. DURING THE EVALUATION AN ADDITIONAL AFFECTED LOT WAS IDENTIFIED AND THEREFORE ADDED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707348 UNI GLENOID-PERIPHERAL LOCK SCRW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW 15.00439 00888867057722

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other