BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 22738482 · Received August 7, 2025

    Report

    Report Number
    1038671-2025-02702
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    June 4, 2008
    Report Date
    August 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 THE REASON FOR THE INTRAOPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION OR HIGH FORCES DURING BROACHING, REAMING, EXPOSURE, OR RETRACTION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION 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

    D10: 1186068: 306-01-08: EQUINOXE, HUMERAL LONG STEM 8 MM 175 MM; 1246625: 300-01-09: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9 MM; 1244687: 300-01-11: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11 MM; 1245215: 320-01-42: EQUINOXE REVERSE 42 MM GLENOSPHERE; 1250521: 320-10-00: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 1233882: 320-15-01: EQ REV GLENOID PLATE; 1237816: 320-15-05: EQ REV LOCKING SCREW; 1238882: 320-20-00: EQ REVERSE TORQUE DEFINING SCREW KIT; 1240388: 320-20-00: EQ REVERSE TORQUE DEFINING SCREW KIT; 1240419: 320-20-00: EQ REVERSE TORQUE DEFINING SCREW KIT; 1221229: 320-20-26: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26 MM; 1247061: 320-20-30: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30 MM; 1209051: 320-20-34: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34 MM; 1118083: 320-20-38: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38 MM; 1100359: 320-42-00: 145-DEG PE 42 MM HUM LINER +0; 1190978: 321-20-00: EQUINOXE REVERSE SHOULDER DRILL KIT; AA1808: 13A2101: CEMEX SYSTEM FAST GENTA 70G; 94629: 620-00-02: PLATELET RICH PLASMA KIT WITH SPRAY TIPS; 6003060806: 620-11-02: ACCELERATE CONC. SYS. 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 DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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 THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. THE PATIENT EXPERIENCED AN INTRAOPERATIVE SPIRAL HUMERAL MIDSHAFT FRACTURE. THE SURGEON REVISED TO A LONG STEM WITH A CERCLAGE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121703 EQUINOXE REVERSE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention SEE H11