BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0

    MDR report key: 18210166 · Received November 27, 2023

    Report

    Report Number
    1038671-2023-02861
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    October 31, 2023
    Report Date
    April 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086679
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6) 320-15-06 - RS GLENOID PLATE EXT CAG +10MM CAGE PEG (B)(6) 320-15-05 - EQ REV LOCKING SCREW (B)(6) 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0 (B)(6) 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT (B)(6) 315-35-00 - GLND KWIRE 5251874 315-35-00 - GLND KWIRE (B)(6) 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (B)(6) 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE (B)(6) 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6) 320-15-05 - EQ REV LOCKING SCREW (B)(6) 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6) 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6) 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM (B)(6) 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 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 REVISION REPORTED WAS LIKELY THE RESULT OF DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY LEADING TO SUBSEQUENT METAL-ON-METAL ARTICULATION BETWEEN UNINTENDED COMPONENTS, MIGRATION, AND PROSTHESIS WEAR. AN ADDITIONAL REASON FOR THE REPORTED REVISION MAY HAVE BEEN INSTABILITY. HOWEVER, THE REPORTED INSTABILITY COULD NOT BE CONFIRMED FROM THE INFORMATION PROVIDED. POTENTIAL CONTRIBUTIONS OF PATIENT AND USER CONSIDERATIONS, AN UNREPORTED TRAUMATIC EVENT, INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), OR A COMBINATION OF THE ABOVE TO THE DISASSEMBLY OF THE HUMERAL LINER CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION, AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WERE NOT 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 A 68 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON OCTOBER 31, 2023. THE PATIENT¿S TRAY AND POLY WERE REVISED DUE TO INSTABILITY. THE XRAY SHOWED THE TRAY RIGHT UP AGAINST THE GLENOSPHERE, (METAL ON METAL), SO THE POLY HAD BECOME DISLODGED. THE +0 TRAY AND 38MM +0 CONSTRAINED LINER WERE SWAPPED FOR A NEW +0 TRAY WITH A 38MM +2.5 CONSTRAINED LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT ABLE TO BE RETURNED AS THE HOSPITAL DOES NOT ALLOW IT. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218767 EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK 10885862086679

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention SEE H10.