BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM

    MDR report key: 18419169 · Received December 29, 2023

    Report

    Report Number
    1038671-2023-03075
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    November 30, 2023
    Report Date
    May 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862283009
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 320-40-03 - 145-DEG PE 40MM HUM LINER +2.5: 7229077 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A412805 320-31-40 - GLENOSPHERE, 40MM: 6933692 320-35-06 - SMALL EXTENDED CAGE GLENOID PLATE: 7033890

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY BE THE RESULT OF THE HUMERAL LOOSENING AS REPORTED. HOWEVER, THE LOOSENING CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM MANUFACTURING, USER, OR PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS NO RADIOGRAPH, IMAGES, OR CLINICAL INFORMATION WAS PROVIDED. D4: CORRECTED H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6)2023. THE PATIENT PRESENTED ON (B)(6) 2023 WITH ASEPTIC HUMERAL LOOSENING. PATIENT REPORTS SIGNIFICANT PAIN. X-RAYS SHOW LUCENCY AROUND CEMENT OF THE HUMERUS, LIKELY INDICATING LOOSENING OF HARDWARE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS CONTINUING. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245497 EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862283009

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female SEE H10