BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8310046 · Received February 6, 2019

    Report

    Report Number
    1038671-2019-00049
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    August 31, 2018
    Report Date
    November 22, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (A1) PATIENT IDENTIFIER (IN CONFIDENCE): (B)(6). (B2) ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D4) EXPIRATION DATE: 08-MAY-2028, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D5) OPERATOR OF DEVICE: HEALTH_CARE_PROFESSIONAL. (D6) IF IMPLANTED, GIVE DATE: (B)(6) 2018. (D7) IF EXPLANTED, GIVE DATE: (B)(6) 2018. (G5) PMA/510(K)NUMBER: K063569. (H3) PATIENT WAS REVISED ON (B)(6) 2018.ONLY THE TRAY, LINER AND GLENOSPHERE WERE REPLACED. (H4) DEVICE MANUFACTURE DATE: 09-MAY-2018. (H5) LABELED FOR SINGLE USE?: YES. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (E1) INITIAL REPORTER: DR. (B)(6). (E2) HEALTH PROFESSIONAL?: YES. (E3) OCCUPATION: PHYSICIAN. (E4) INITIAL REPORTER ALSO SENT REPORT TO FDA?: NO. (G1) MDR REPORTING CONTACT: (B)(6). (G3) REPORT SOURCE: HEALTH PROFESSIONAL .

    Additional Manufacturer Narrative · 0

    D4: ADDED SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    THE ENGINEERING EVALUATION NOTED THAT THE REVISION REPORTED WAS LIKELY THE RESULT OF HETEROTROPIC OSSIFICATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2018. REVISION DUE TO HETEROTOPIC OSSIFICATION. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104136 EQUINOXE EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R