BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REV LOCKING SCREW

    MDR report key: 21263630 · Received January 29, 2025

    Report

    Report Number
    1038671-2025-00521
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    December 23, 2024
    Report Date
    May 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086495
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANTS: A515639 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM A373979 315-35-00 - GLND KWIRE A123870 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE A495898 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A269877 320-15-01 - EQ REV GLENOID PLATE A500944 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A157145 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM S423951 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S416818 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 6892476 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT H3: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION WAS LIKELY DUE TO FRACTURE OF THE GLENOSPHERE LOCKING SCREW LEADING TO UNINTENDED CONTACT WITH THE LINER AND SUBSEQUENT POLYETHYLENE WEAR. THE REASON FOR THE FRACTURE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED, BUT MAY BE RELATED TO INCOMPLETE SEATING OF THE LOCKING SCREW AND/OR PARTIALLY DISASSEMBLY OF THE DEVICE. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE INFORMATION 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 THIS PATIENT'S SHOULDER WAS REIVSED APPROXIMATELY 1 YEAR 6 MONTHS POST INITIAL OPERATION. IT WAS SUSPECTED THAT THE GLENOSPHERE SCREW HAD BACKED OUT. HOWEVER, SURGEON HAD FOUND THAT THE GLENOSPHERE SCREW HAD BROKEN INTO THE GLENOID BASEPLATE. THE SCREW HAD SUBSEQUENTLY BACKED OUT AND WEARING THE HUMERAL POLY CAUSING LYSIS. AFTER REMOVAL, SURGEON RE INSERTED A LONG PEG BASEPLATE AND NEW IMPLANTS AS THE STEM WAS WELL FIXED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511020 EQ REV LOCKING SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086495

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H11