BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 11086722 · Received December 29, 2020

    Report

    Report Number
    1038671-2020-00670
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 10, 2020
    Report Date
    December 29, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276193
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOOSENING REPORTED WAS LIKELY THE RESULT OF EITHER AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, PATIENT-RELATED CONDITIONS RELATED TO MEDICAL HISTORY AND/OR PREVIOUS OPERATIONS ON INVOLVED ANKLE, OR A COMBINATION OF THE TWO. HOWEVER, THIS CANNOT BE CONFIRMED AS THE PATIENT HAS NOT YET BEEN REVISED; THEREFORE, THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICE(S): 350-22-62, TIBIAL INSERT FB SZ 2 RT 12MM, 350-02-01, TALAR IMPLANT SZ 1 RT.

    Description of Event or Problem · 1

    AS REPORTED, THE (B)(6) MALE PATIENT PRESENTED WITH PAIN "LIKE BEFORE MY SURGERY" AFTER BEGINNING A WALKING PROGRAM. PATIENT¿S BMI IS (B)(6), WEIGHT IS (B)(6). X-RAYS SHOW CYST FORMATION AND EARLY LOOSENING IN RIGHT ANKLE. THE PATIENT WAS INSTRUCTED TO REDUCE WALKING AND RETURN IN 2 MONTHS. PATIENT HAS A HISTORY OF POST TRAUMATIC ARTHRITIS, HYPERTENSION, A-FIB; PAD; H/O PULMONARY EMBOLISM & SKIN CANCER. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550858 VANTAGE TIBIAL PLATE FB SZ 3 RT HSN EXACTECH, INC. 350-12-03 UNK 10885862276193

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R