BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 46MM HUMERAL LINER +0

    MDR report key: 18862796 · Received March 7, 2024

    Report

    Report Number
    1038671-2024-00436
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    October 1, 2021
    Report Date
    May 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086730
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-30-12 - EQUINOXE PRESERVE STEM 12MM: 5126770, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5171492, 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE: 5155113, 320-15-01 - EQ REV GLENOID PLATE: 5185523, 320-15-05 - EQ REV LOCKING SCREW: 5125547, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5080453, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 4981000, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 5171677, 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: 5087666, 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 5153789, (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED MAY HAVE BEEN DUE TO DISASSEMBLY. HOWEVER, THE REPORTED DISASSEMBLY COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT, AN UNREPORTED TRAUMATIC EVENT, INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), OR A COMBINATION OF THE ABOVE TO THE REPORTED DISASSEMBLY OF THE HUMERAL LINER CANNOT BE DETERMINED 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A LEFT TSA ON (B)(6) 2018 AND PRESENTED WITH DISASSOCIATION OF POLYETHYLENE, ON (B)(6) 2019, PATIENT REACHED BACK AND HAD A SHARP PAIN. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2021. THE ACTION TAKEN WAS REVISION-STANDARD REVERSE WITH THE REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195846 EQUINOXE REVERSE 46MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086730

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male SEE H10.