BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM GLENOSPHERE

    MDR report key: 15983674 · Received December 14, 2022

    Report

    Report Number
    1038671-2022-01602
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    December 3, 2022
    Report Date
    February 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. CONCOMITANT MEDICAL DEVICE: 300-01-09, 3674913 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM, 315-15-05, 3931094 - GLENOSPHERE LOCKING SCREW (PRODUCT NOT IN SS), 320-38-00, 3944722 - EQUINOXE REVERSE 38MM HUMERAL LINER +0, 320-10-00, 3975237 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-20-00, 3959446 - EQ REVERSE TORQUE DEFINING SCREW KIT, 320-15-01, 3935594 - EQ REV GLENOID PLATE.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THIS FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2015. THE PATIENT WAS REVISED DUE TO INFECTION. A WASHOUT WAS PERFORMED AND THE LINER AND GLENOSPHERE WERE EXCHANGED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438046 EQUINOXE REVERSE 38MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-01-38 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention