BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE 145-DEG PE 46MM HUM LINER +0

    MDR report key: 20456508 · Received October 15, 2024

    Report

    Report Number
    1038671-2024-03991
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 12, 2022
    Report Date
    September 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086730
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-30-06 - EQUINOXE PRESERVE STEM 6MM: (B)(6), 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: (B)(6), 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE: (B)(6), 320-15-01 - EQ REV GLENOID PLATE: (B)(6).

    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 REPORTED WAS LIKELY THE RESULT OF DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY. HOWEVER, THIS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS FROM USER-RELATED CONSIDERATIONS, 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 REPORTED DISASSEMBLY OF THE HUMERAL LINER CANNOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES/RADIOGRAPHS 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

    APPROXIMATELY 3 YEAR(S), 10 MONTH(S) AND 5 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. PATIENT TRIED TO BRACE HIMSELF FROM FALLING OFF A LADDER. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558570 EQUINOXE 145-DEG PE 46MM HUM LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086730

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H11.