BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0

    MDR report key: 15481974 · Received September 25, 2022

    Report

    Report Number
    1038671-2022-01158
    Event Type
    Injury
    Date Received
    September 25, 2022
    Date of Event
    August 30, 2022
    Report Date
    February 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086716
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 7016219 300-30-10 - EQUINOXE PRESERVE STEM 10MM, A078016 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET, A072159 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, A072830 320-15-05 - EQ REV LOCKING SCREW, A037209 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, A001538 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0.

    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.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. THE PATIENT WAS DEEMED STABLE AFTER THE REVISION. THERE WAS NO REPORTED BREAKAGE OF DEVICE(S) OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES ARE NOT RETURNING DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535205 EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-42-10 10885862086716

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention SEE H10