BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA)

    MDR report key: 19009221 · Received March 30, 2024

    Report

    Report Number
    1038671-2024-00693
    Event Type
    Injury
    Date Received
    March 30, 2024
    Date of Event
    February 7, 2023
    Report Date
    July 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862083999
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S: A188948; 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: A090781, 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: A181278. (H3) PENDING EVALUATION.

    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: A, B, C, D, E, G. THE REASON FOR THE REPORTED REVISION DUE TO SUBLUXATION AND INSTABILITY CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, ROTATOR CUFF FAILURE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. SUBLUXATION AND INSTABILITY ARE KNOWN RISKS, AS OUTLINED IN THE IFU. 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 64-YEAR-OLD MALE PATIENT HAD A LEFT TSA ON (B)(6) 2022. THE PATIENT PRESENTED WITH A INSTABILITY / SUBLUXATION ON (B)(6) 2023. SHOULDER CONTINUED TO SUBLUXATE POST-OPERATIVELY, ESPECIALLY AT NIGHT. PATIENT ALSO DEVELOPED A FISTULA AND A DRAINING SINUS. THIS EVENT IS RELATED TO (B)(4). THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2023 BY THE ACTION OF REVISION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253215 EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA) PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862083999

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male SEE H10