BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID S, POST AUG, RIGHT

    MDR report key: 17172535 · Received June 21, 2023

    Report

    Report Number
    1038671-2023-01424
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    February 15, 2022
    Report Date
    June 21, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862201003
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 0961618 300-30-09 - EQUINOXE PRESERVE STEM 9MM; 0961618 300-51-15 - 1.5 SHORT FA REP PLT KIT; 0961618 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA); 0961618 315-35-00 - GLND KWIRE; 0961618 531-78-20 - SHOULDR GPS HEX PINS KIT. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, WHO HAD AN INITIAL RIGHT SHOULDER PROCEDURE ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 6 MONTHS POST THE INITIAL PROCEDURE. HER GLENOID COMPONENT FAILED DUE TO POOR BONE QUALITY, ¿SHE HAD BEEN RADIATED AND HAD POOR GENERAL HEALTH. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216208 EQUINOXE CAGE GLENOID S, POST AUG, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, RIGHT UNK 10885862201003

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention