BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24MM BASEPLATE, MODULAR

    MDR report key: 11485611 · Received March 15, 2021

    Report

    Report Number
    1220246-2021-02754
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 15, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867296411
    PMA / PMN Number
    K173900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF AN ARTHREX PROSTHETIC JOINT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLICATION WAS REPORTED ON (B)(6) 2020; INDICATING LOOSENING OF PROSTHETIC JOINT AND A REVISION REQUIRED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9560-24 (LOT: 5655). AR-9561-20P (LOT: 7038). AR-9562-36NL (LOT: 2018005757). AR-9562-40NL (LOT: 2018001457). AR-9563-20 (LOT: 2019003063). AR-9564-2436-LAT (LOT: 19.03388). AR-9502F-36RCPC (LOT: 19.00394). AR-9503S-06 (LOT: 170052510). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36RCPC (LOT: 20.01053). AR-9555-06 (LOT: 170143213). AR-9503S-06 (LOT: 20.01369).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383325 24MM BASEPLATE, MODULAR SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. 24MM BASEPLATE, MODULAR 5655 00888867296411

    Patients

    Seq Age Sex Outcome Treatment
    1 Other