BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM GLENOSPHERE

    MDR report key: 17233753 · Received June 29, 2023

    Report

    Report Number
    1038671-2023-01512
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    November 1, 2022
    Report Date
    June 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    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. CONCOMTANTS: 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B2 B3: DATE OF EVENT AN UNKNOWN DATE IN NOVEMBER OF 2022. D1. D7A. H6: HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE GLENOID BASEPLATE AND BONE INTERFACE LEADING TO ASEPTIC LOOSENING. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WERE 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 VIA CLINICAL STUDY THAT THE 60 YO MALE PATIENT ASEPTIC GLENOID LOOSENING. LOOSE RTSA BASEPLATE IN PREVIOUSLY REVISION FROM TSA. NO MOI NOTED. THE DATE OF EVENT ONSET IS (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823383 EQUINOXE REVERSE 38MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other| R SEE H10.