BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 16312335 · Received February 7, 2023

    Report

    Report Number
    1038671-2023-00114
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    January 10, 2023
    Report Date
    December 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862171511
    PMA / PMN Number
    K110706
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 7278662 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 7122028 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 7273947 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: H6 BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 64 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 MONTHS POST THE INITIAL PROCEDURE. THE HEMI SHOULDER WAS CONVERTED TO A REVERSE SHOULDER AT THE PATIENT¿S REQUEST. THE PATIENT COMPLAINED OF NO RANGE OF MOVEMENT AND PAIN ON THE LEFT SHOULDER. THE SURGEON DID A REVERSE ON HER OTHER SIDE, AND SHE WANTED HER HEMI CONVERTED TO REVERSE TO FEEL THE BENEFITS OF THE RANGE OF MOTION THAT SHE EXPERIENCES WITH HER OTHER SIDE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING AS IT WAS DISCARDED BY HOSPITAL. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82285 EQUINOXE PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. CTA HUMERAL HEAD SHORT, 47MM UNK 10885862171511

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H10