BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

    MDR report key: 17471786 · Received August 7, 2023

    Report

    Report Number
    1038671-2023-01882
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    June 23, 2023
    Report Date
    May 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086709
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3000115. REVERSE GLENOSPHERE 3200142. REVERSE HUMERAL TRAY 3201000. REVERSE GLENOSPHERE BASEPLATE 3201503.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D1/D2A/D2B, D4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. THE REVISION REPORTED MAY HAVE BEEN DUE TO DISASSEMBLY. HOWEVER, THE REPORTED DISASSEMBLY COULD NOT BE CONFIRMED. 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 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

    IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 4 YEARS POSTOP THE INITIAL IMPLANT, THIS 77 YO MALE PATIENT WAS REVISED DUE TO DISASSOCIATION OF POLYETHYLENE. THE PATIENT ROLLED OVER IN BED AND FELT A POP. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481608 EQUINOXE REVERSE 42MM HUMERAL LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086709

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| O SEE H10.