BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 8MM

    MDR report key: 17295222 · Received July 10, 2023

    Report

    Report Number
    1038671-2023-01597
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    May 31, 2023
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862282996
    PMA / PMN Number
    K093275
    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 3000108. REVERSE HUMERAL TRAY 3201000. REVERSE GLENOSPHERE 3203136. REVERSE GLENOSPHERE BASEPLATE 3203508.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 73 YO FEMALE PATIENT EXPERIENCED A HUMERAL FRACTURE WHICH OCCURRED INTRA-OPERATIVELY. THE MINIMALLY DISPLACED TUBEROSITY FRACTURE WAS NOTED IMMEDIATELY POST-OP AND NOW DISPLACED AT FPO VISIT. THERE WAS NO ACTION TAKEN. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587618 EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 8MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK UNK 10885862282996

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention| O SEE H10