BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE ANATOMIC SHOULDER COMPONENTS

    MDR report key: 22073605 · Received May 22, 2025

    Report

    Report Number
    1038671-2025-02129
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    July 13, 2023
    Report Date
    May 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: ((B)(6)) 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. ((B)(6)) 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. ((B)(6)) 315-35-00 - GLND KWIRE. ((B)(6)) 300-01-12 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM. ((B)(6)) 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT REPLICATOR PLATE 4.5MM O/S. ((B)(6)) 314-13-15 - EQUINOXE CAGE GLENOID EXTRA LARGE, BETA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2025-00089. THE REASON FOR THE REVISION REPORTED IN THIS CASE CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, 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.

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, INFLAMMATION, LIMITED RANGE OF MOTION AND COMPONENT LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1413-2024 314-13-15 - EQUINOXE CAGE GLENOID EXTRA LARGE, BETA. SERIAL: (B)(6). 510K: K113309. UDI: (B)(4). PRODUCT CODE: KWS. X-RAY: NO. OPERATIVE NOTES: NO. CONCOMITANT DEVICES: ((B)(6)) 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. ((B)(6)) 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. ((B)(6)) 315-35-00 - GLND KWIRE. ((B)(6)) 300-01-12 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM. ((B)(6)) 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT REPLICATOR PLATE 4.5MM O/S. LEGAL CASE: USA. PATIENT ID: (B)(6). 13. PLAINTIFF (B)(6) IS RESIDENT OF (B)(6). ON (B)(6) 2017, PLAINTIFF, UNDERWENT SHOULDER REPLACEMENT SURGERY OF THE RIGHT SHOULDER AT (B)(6) IN (B)(6). ON (B)(6) 2017, HE UNDERWENT REPLACEMENT SURGERY FOR HIS LEFT SHOULDER. ON BOTH OCCASIONS, PLAINTIFF WAS IMPLANTED WITH AN EXACTECH EQUINOXE SHOULDER SYSTEM. 14. AFTER SURGERY, PLAINTIFF BEGAN EXPERIENCING SEVERE PAIN AND DISCOMFORT, INFLAMMATION, AND NUMEROUS OTHER HEALTH PROBLEMS. 15. DUE TO PLAINTIFF¿S PAIN, DISCOMFORT, AND OTHER SYMPTOMS, IN 2023, PLAINTIFF WAS SEEN BY HIS ORTHOPEDIC WHO RECOMMENDED REVISION SURGERY FOR BOTH SHOULDERS. REVISION OF THE LEFT SHOULDER WAS PERFORMED ON (B)(6) 2023. REVISION OF THE RIGHT SHOULDER WAS PERFORMED ON (B)(6) 2023. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF EXACTECH¿S CONDUCT AND THE DEFECTIVE NATURE OF THE EXACTECH DEVICES AS DESCRIBED HEREIN, PLAINTIFF HAS S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513789 EQUINOXE ANATOMIC SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H