BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE COMPRESSION SCREW

    MDR report key: 19857340 · Received July 29, 2024

    Report

    Report Number
    1038671-2024-02580
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    April 11, 2024
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 6612419 - 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 6589796 - 320-01-36 - 36MM GLENOSPHERE. 6677928 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 6628461 - 320-15-05 - EQ REV LOCKING SCREW. 6552988 - 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE. 6642518 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S064650 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S092961 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S066037 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S082295 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S099376 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S113258 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 6635106 - 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED. 6616804 - 531-20-00 - SHLDR GPS RVRS DRILL KIT. 6616993 - 531-78-20 - SHOULDR GPS HEX PINS KIT. 6706271 - 531-78-20 - SHOULDR GPS HEX PINS KIT. 3009120095 - A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    H3: THE SCAPULAR FRACTURE REPORTED IN (B)(4) IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND BONE QUALITY. THE FRACTURE OF THE INFERIOR COMPRESSION SCREW IS MOST LIKELY SECONDARY TO THE SCAPULAR FRACTURE AND SUBSEQUENT SUBJECTION OF THE COMPRESSION SCREW TO HIGH LOADS RESULTING IN THE MATERIAL FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR PHOTOS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-01089 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE SCAPULAR FRACTURE REPORTED IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND BONE QUALITY. THE FRACTURE OF THE INFERIOR COMPRESSION SCREW IS MOST LIKELY SECONDARY TO THE SCAPULAR FRACTURE AND SUBSEQUENT SUBJECTION OF THE COMPRESSION SCREW TO HIGH LOADS RESULTING IN THE MATERIAL FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR PHOTOS WERE 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, APPROXIMATELY 3 YEARS AND 5 MONTHS POST INITIAL TSA, THE PATIENT WAS REVISED. THE PATIENT EXPERIENCED A SCAPULA FRACTURE AND THE BASEPLATE AND GLENOSPHERE SPUN 180 DEGREES AND WAS UPSIDE DOWN. THE INFERIOR SCREW HAD BROKEN. THERE WAS METALOSIS AS A RESULT OF THE IMPLANT ARTICULATING AT AN ACUTE ANGLE. THE STEM WAS STILL WELL FIXED AND THERE WAS NO PRESENCE OF INFECTION. THE PATIENT IS A RHEUMATOID ARTHRITIS SUFFERER AND THERE WAS SIGNIFICANT RESORBTION OF THE TUBEROSITIES. ALL IMPLANTS WERE REMOVED EXCEPT THE STEM. A NEW ANATOMIC REPLICA PLATE, SCREW AND A CTA HEAD WERE IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200552 EQUINOXE COMPRESSION SCREW PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H