BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 14687903 · Received June 14, 2022

    Report

    Report Number
    1038671-2022-00685
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 11, 2022
    Report Date
    September 2, 2022
    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

    DEVICE EVALUATED BY MFR: PENDING EVALUATION. ETHNICITY, RELEVANT TEST/LABORATORY DATA, SERIAL #, DEVICE MANUFACTURE DATE, AND RECALL: NO INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    SECTION H10: (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 SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 YEARS POST OP THE INITIAL TSA, THIS 78 Y/O MALE PATIENT WAS REVISED DUE TO SEPTIC LOOSENING. SUBJECT STARTING HAVING SEVERE LEFT SHOULDER PAIN AFTER UNRELATED HOSPITALIZATION-EXACT MOI/DATE UNK. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687058 EQUINOXE SHOULDER COMPONENTS KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R SEE H10