BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 17046033 · Received June 2, 2023

    Report

    Report Number
    1038671-2023-01211
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    April 28, 2023
    Report Date
    September 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3000110. REVERSE HUMERAL LINER 3203800. REVERSE GLENOSPHERE 3200638. REVERSE GLENOSPHERE BASEPLATE 3201502.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, G4, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, F, G 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 CONDITION OR HIGH FORCES DURING BROACHING, REAMING, EXPOSURE, OR RETRACTION. 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 63 YO MALE PATIENT EXPERIENCED AN INTRA-OP CALCAR/HUMERAL FRACTURE. THE ACTION TAKEN WAS ¿ORIF WITH CABLE DURING SURGERY.¿ THE OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322887 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-10-00 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| O SEE H10.