BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 19629141 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02185
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 22, 2024
    Report Date
    October 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862079329
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5 H3: THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO A PERIPROSTHETIC BONE FRACTURE. THE CAUSE OF THE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. H6: COMPONENT CODE, INVESTIGATION CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4319701 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S 4162786 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT 3616644 310-02-47 - EQUINOXE, HUMERAL HEAD TALL, 47MM (BETA) 3795623 314-02-34 - UHMWPE POST AUG GLENOID LARGE, RIGHT 5660547 315-35-00 - GLND KWIRE 5441957 531-20-00 - SHLDR GPS RVRS DRILL KIT 5504085 531-78-20 - SHOULDR GPS HEX PINS KIT 08013018182 A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    HUMERAL BONE FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) OF 2019, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 4 MONTHS POST THE INITIAL PROCEDURE DUE TO PERIPROSTHETIC FRACTURE. THE PATIENT WAS REVISED TO AN EQUINOXE REVERSE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS AS THEY WERE DISPOSED BY THE CUSTOMER. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820022 EQUINOXE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862079329

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention SEE H11.