BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 20251592 · Received September 18, 2024

    Report

    Report Number
    1038671-2024-03616
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    June 5, 2018
    Report Date
    June 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A REVIEW OF COMPLAINT HISTORY WAS UNABLE TO BE PERFORMED AS THE RELEVANT DEVICE AND EVENT INFORMATION WAS UNKNOWN. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM HUMERAL BONE FRACTURE OCCURRING FROM A PATIENT FALL LEADING TO HUMERAL LOOSENING. HOWEVER, THE LOOSENING CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM MANUFACTURING, USER, OR PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE 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

    CONCOMITANT DEVICE(S): 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 3959310; 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 4051674; 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 4062972; 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE: 4021340; 320-38-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5: 3913086; 320-15-05 - EQ REV LOCKING SCREW: 4056453; 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 4044563; 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 4070156; 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 4017260; 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 4062727; 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 4034721; 652-00-05 - OPTECURE WITH CCC - 5CC: 3972332; ASA0030 - STERILE DISPOSABLE CONTAINERS: AA7857; CNL-09 - SMALL CEMENT CANNULA: AA6546; 13A2101 - CEMEX SYSTEM FAST GENTA 70G: AA8313.

    Description of Event or Problem · 0

    APPROXIMATELY 2 YEAR(S), 9 MONTH(S) AND 19 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED AN ORTHOPEDIC EVENT OF NON-UNION OF HUMERAL FRACTURE AND HARDWARE LOOSENING. PATIENT SUSTAINED A GLF AND UNDERWENT ORIF OF PERIPROSTHETIC HUMERAL FRACTURE WITH ILIAC CREST ASPIRATE AND OPTECURE BONE GRAFTING. HOWEVER, THIS HAS FAILED, AS THE PATIENT HAS CONTINUED PAIN AND DECREASED ROM. THE PATIENT UNDERWENT STANDARD REVERSE REVISION AND WAS REVISED FROM RTSA TO HRP. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526541 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female SEE H11