BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20909806 · Received December 11, 2024

    Report

    Report Number
    1038671-2024-04781
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 19, 2024
    Report Date
    March 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. 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

    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. D10: A10012 - GPS IMPLANT KIT V2 03008421076, 320-15-03 - RS GLENOID PLATE POST AUG, 8 DEG, LEFT 6554002, 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM 6715702, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE 6747881, 320-15-05 - EQ REV LOCKING SCREW 6827642, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6867456, 531-78-20 - SHOULDR GPS HEX PINS KIT 6873143, 531-78-20 - SHOULDR GPS HEX PINS KIT 6873684, 531-20-00 - SHLDR GPS RVRS DRILL KIT 6894031, 315-35-00 - GLND KWIRE 6901568, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6910006, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S110702, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM S117491, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S209174, 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0 S232199, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S234919.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS AND 6 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT EXPERIENCED SORENESS AND SWELLING, CONFIRMED TO BE INFECTION OF THE PROSTHESIS, POSSIBLY P. ACNES. THE PATIENT HAD A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE PERFORMED. SIGNIFICANT INFECTION PRESENTED BEHIND THE GLENOSPHERE. THE HUMERAL STEM WAS WELL FIXATED AND RETAINED. THE GLENOSPHERE, LINER, AND ADAPTER TRAY WERE EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152016 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H SEE H11.