BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 46MM HUM LINER +2.5

    MDR report key: 20239068 · Received September 17, 2024

    Report

    Report Number
    1038671-2024-03559
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086747
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6599706 300-30-06 - EQUINOXE PRESERVE STEM 6MM. 6567319 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 6496707 320-15-01 - EQ REV GLENOID PLATE. 6489612 320-15-05 - EQ REV LOCKING SCREW. 6615980 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S086096 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S080662 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S083587 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 6023499 320-02-46 - 46X21MM GLENOSPHERE HIGH MOMENT ARM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: G3, H6, H11 MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G THE REVISION WAS LIKELY THE RESULT OF DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY LEADING TO THE HUMERAL LINER BACKSIDE WEAR. POTENTIAL CONTRIBUTIONS FROM PATIENT CONDITIONS, 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. 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 81 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 4 YEARS POST OP. SURGEON REVISED AN EXACTECH REVERSE SHOULDER DUE TO A DISPLACED 46 LINER. HE REMOVED A 46 INSET GLENOSPHERE AND DISPLACED LINER AND REPLACED WITH A 42+4 GLENOSPHERE AND A 42, CONSTRAINED, 135 DEGREE LINER WITH NEW LOCKING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526348 145-DEG PE 46MM HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086747

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention SEE H11.