BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID S, POST AUG, RIGHT

    MDR report key: 19203914 · Received April 29, 2024

    Report

    Report Number
    1038671-2024-01005
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    March 5, 2024
    Report Date
    October 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862201003
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): AB0646 - 13A2101 - CEMEX SYSTEM FAST GENTA 70G, AB0991 - 13A2111 - CEMEX SYSTEM FAST GENTA 40G, 1896962 - 300-01-07 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM, 5093274 - 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM, 5128477 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT, 5182909 - 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT, 5151345 - 300-50-45 - 4.5MM SHORT REP PLATE, 5028015 - 310-01-47 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA), 4250976 - 314-13-32 - EQUINOXE CAGE GLENOID S, POST AUG, RIGHT, 8012017045 - A10012 - GPS IMPLANT KIT V2, AB0898R - CNL-09 - SMALL CEMENT CANNULA.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D2A, D2B, G1, H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, DISLOCATION, ROTATOR CUFF TEAR, AND/OR PATIENT RELATED FACTORS. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED. THE RADIOGRAPH PROVIDED APPEARS UNREMARKABLE. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT SHOULDER WAS REVISED 5 YEARS 10 MONTHS POST OP INITIAL SURGERY. SURGEON VOICED HIS CONCERNS ABOUT THE GLENOID TO (B)(6) AFTER A ANATOMIC TO REVERSE REVISION SURGERY AND AFTER HE FOUND OUT ABOUT A RECALL. GLENOID WAS REVISED TO COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, HOSPITAL KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999106 EQUINOXE CAGE GLENOID S, POST AUG, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK 10885862201003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention