BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 20724834 · Received November 19, 2024

    Report

    Report Number
    1038671-2024-04429
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 28, 2024
    Report Date
    August 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM, 7140584; 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S, 7137479; 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT, 7157074; 310-02-47 - EQUINOXE, HUMERAL HEAD TALL, 47MM (BETA), 6290231; 314-13-13 - EQUINOXE CAGE GLENOID MEDIUM, BETA, 7149731; 321-52-09 - 3.2MM K-WIRE, TROCAR TIP, 7176926; 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK, 7204547.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO 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 RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS AND 7 MONTHS POST THE INITIAL LEFT ANATOMIC TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED. PULLED OUT GLENOID, REPLICATOR PLATE, AND ANATOMIC HEAD, AND REPLACED WITH REVERSE COMPONENTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56309 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H