BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE COMPRESSION SCREW

    MDR report key: 20203777 · Received September 12, 2024

    Report

    Report Number
    1038671-2024-03490
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 21, 2024
    Report Date
    March 3, 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

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6964031- 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 6999547- 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 6984708- 320-15-05 - EQ REV LOCKING SCREW. 6803430- 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S129361 -320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. S266873- 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. S274653- 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S253051- 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 7001042- 320-31-36 - GLENOSPHERE, 36MM. 6993009- 320-35-01 - SMALL GLENOID PLATE. 7025384- 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED. 6475155- 531-20-00 - SHLDR GPS RVRS DRILL KIT. 6974436- 531-20-00 - SHLDR GPS RVRS DRILL KIT. 6954857- 531-78-20 - SHOULDR GPS HEX PINS KIT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6. H3: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. THE INVESTIGATION RESULTS CONCLUDED THAT THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED SCREW BREAKAGE WAS LIKELY DUE TO CHANGES IN BONE QUALITY AND SUBSEQUENT STRESS ON THE IMPLANT RELATED TO THE INFECTION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED SCREW BREAKAGE WAS LIKELY DUE TO CHANGES IN BONE QUALITY AND SUBSEQUENT STRESS ON THE IMPLANT RELATED TO THE INFECTION. 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 FEMALE PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 3 YEARS POST OP. PATIENT HAD AN INFECTION FOLLOWED BY SCREW BREAKAGE IN THE GLENOID. PATIENT WAS NOT REVISED TO EXACTECH DEVICES. EVERYTHING WAS REMOVED AND REPLACED BY A NEW REVERSE SHOULDER WITH CEMENTED STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473289 EQUINOXE COMPRESSION SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.