BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20553138 · Received October 28, 2024

    Report

    Report Number
    1038671-2024-04151
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    September 25, 2024
    Report Date
    August 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    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: B154808, 322-42-00 - 145-DEG PE 42MM HUM LINER +0: B203340, 322-10-00 - HUMERAL ADAPTER TRAY, +0: B207116, 320-06-42 - GLENOSPHERE 42MM: B168017, 320-15-06 - RS GLENOID PLATE EXT CAG +10MM CAGE PEG: B127571.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE INTRAOPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION 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

    INTRA-OPERATIVELY OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A HUMERAL FRACTURE - GREATER TUBEROSITY. THE ACTION TAKEN DURING THE PROCEDURE WAS ORIF/SUTURE REPAIR OF TUBEROSITY AND THE OUTCOME OF THIS EVENT REMAINS CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302285 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention SEE H11.