BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36 +4 LAT/24 GLENOSPHERE

    MDR report key: 10414375 · Received August 17, 2020

    Report

    Report Number
    1220246-2020-02039
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867295681
    PMA / PMN Number
    K173900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    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 A PATIENT HAD UNDERGONE AN SHOULDER PROCEDURE (B)(6) 2019. DUE TO UPPER ARM/ BICEPS TENDON PAIN AND DISCOMFORT THE ORIGINAL SURGEON PERFORMED A REVISION RTSA PROCEDURE (B)(6) 2020 AT THE SAME FACILITY. DURING THE REVISION PROCEDURE WHILE ATTEMPTING TO REMOVE THE CUP SCREW FROM THE ORIGINAL PROCEDURE THE DRIVER TIP TWISTED AND THE SCREW STRIPPED. SALES REP STATES NOTHING OUT OF THE ORDINARY WAS NOTICED/ MENTIONED BY THE SURGEON DURING THE PROCEDURE. THE REVISION WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION AND EXCHANGED FOR LARGER SIZES: AR-9564-2436-LAT (LOT 18.01992), AR-9501-07P (LOT 18.02015), AR-9502F-36RCPC (LOT 170111405), AR-9503S-06 (LOT 19.00773), AR-9502RSC (LOT 18.01082). THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881475 36 +4 LAT/24 GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. 36 +4 LAT/24 GLENOSPHERE 18.01992 00888867295681

    Patients

    Seq Age Sex Outcome Treatment
    1 Other