BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 19934628 · Received August 7, 2024

    Report

    Report Number
    1038671-2024-02737
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2378126- 201-78-14 - HOLDING PIN HEADLESS SHARP POINT LONG 4PK. 2698981- ,300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 2840063 -300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 4231899- 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 2380167 -310-03-53 - EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA). 2536921 -314-02-12 - EQUINOXE GLENOID, PEGGED BETA, SMALL. 4365768 -315-35-00 - GLND KWIRE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, INFECTION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS 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

    IT WAS REPORTED THAT A 83 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 8 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE IN-SITU ANATOMIC TOTAL SHOULDER, REMOVING ALL IMPLANTS EXCEPT FOR HUMERAL STEM, AND CONVERTED TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE NOT ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE AS THE HOSPITAL RETAINS THEM. NO IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210841 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention SEE H11