BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 16908163 · Received May 10, 2023

    Report

    Report Number
    1038671-2023-00961
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    January 4, 2023
    Report Date
    July 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 4979963 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 4987955 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE, 5149241 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 5160950 315-35-00 - GLND KWIRE, 5172286 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM, 5190906 320-15-05 - EQ REV LOCKING SCREW, 5235420 300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM, 5249988 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, 5250101 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, 5254802 320-15-01 - EQ REV GLENOID PLATE. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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 A 71 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT HAD AN UNSTABLE SHOULDER. THE POLY WAS INCREASED TO TIGHTEN UP THE SHOULDER. THE REPORTED INFORMATION INDICATED THAT THERE WAS NO FAILURE OF THE SHOULDER COMPONENTS, THE PATIENT¿S SHOULDER LOOSENED UP POST-SURGERY. THERE WERE NO DEVICE BREAKAGE OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. REASON UNKNOWN. NO DEVICE IMAGES OR X-RAYS WERE PROVIDED. NO PATIENT HISTORY PROVIDED. THE REPORT INDICATED THAT DUE TO HIPPA COMPLIANCE, THE SURGEON'S OFFICE NOR THE HOSPITAL SYSTEM WILL GIVE PATIENT INFORMATION ANYMORE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227999 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention