BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 17075549 · Received June 6, 2023

    Report

    Report Number
    1038671-2023-01264
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    October 1, 2020
    Report Date
    September 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3000109. REVERSE HUMERAL TRAY 3201000. REVERSE GLENOSPHERE 3200138. REVERSE GLENOSPHERE BASEPLATE 3201501.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF ACROMION SURGICAL FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND CAN BE A FORESEEABLE SIDE EFFECT OF USING GPS NAVIGATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. H3: DEVICE WAS NOT EVALUATED OR RETURNED.

    Additional Manufacturer Narrative · 0

    *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 79 YO FEMALE PATIENT EXPERIENCED AN ACROMIAL FRACTURE (TYPE 1). THE PATIENT WAS REVIEWED 15 MONTHS AFTER THE SURGERY FOR SEVERE PAIN. THE X-RAY AND PHYSICAL EXAMINATION SUGGEST ACROMION STRESS FRACTURE. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD NOT BEEN REVIEWED SINCE (B)(6) 2020. THE FRACTURE HAS PROBABLY HEALED. A PRESCRIPTION FOR CONTROL X-RAY WAS SENT TODAY. THERE WAS NO ACTION TAKEN. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020888 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other| R SEE H10.