BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20384937 · Received October 7, 2024

    Report

    Report Number
    1038671-2024-03835
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    July 24, 2024
    Report Date
    December 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10): CONCOMITANT DEVICE(S): 320-42-03 - EQUINOXE REVERSE 42MM HUMERAL LINER +2.5: A620000. 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 6542018. 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 5812167. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6681057. 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT: 6599801. 320-15-05 - EQ REV LOCKING SCREW: 6708511. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6521965. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: S064183. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: S084868. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S114380. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: S105169.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. G4: 510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO LONG TERM SEQUELA FROM THE REPORTED TRAUMATIC EVENT, SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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

    APPROXIMATELY 7 DAYS POST-OPERATIVE OF A REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A DISLOCATION - NEW OCCURRENCE OF DISLOCATION 7 DAYS AFTER. PREVIOUSLY CAPTURED ON (B)(4) IS A FRACTURE OF THE UPPER END OF THE HUMERUS FOLLOWING A FALL FROM A BICYCLE, RESULTING IN SIGNIFICANT OSTEOLYSIS AND INSTABILITY OF THE PROSTHESIS, LEADING TO COMPLETE DISLOCATION. THE PATIENT UNDERWENT A SECOND STANDARD REVERSE REVISION WITH THE REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, AND HUMERAL LINER. THE OUTCOME IS CONSIDERED RESOLVED AND 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
    2539057 EQUINOXE REVERSE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R SEE H11