BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 8449381 · Received March 25, 2019

    Report

    Report Number
    1038671-2019-00179
    Event Type
    Injury
    Date Received
    March 25, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 27, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (A1) PATIENT IDENTIFIER: (B)(6). (A2) AGE AT THE TIME OF EVENT: 71 YEARS . (B2) ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D4) SERIAL NUMBER: (B)(6), EXPIRATION DATE: 19-FEB-2028, UNIQUE IDENTIFIER (UDI) #: (B)(4). INITIAL REPORTER OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K152217. (H3) THE LOOSENING REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE TIBIAL COMPONENT AND PAIN. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT AVAILABLE FOR EVALUATION. (H4) DEVICE MANUFACTURE DATE: 21-FEB-2018 (H6) EVALUATION CODES: 1924, 4002 SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (E2) HEALTH PROFESSIONAL?: YES. (G3) SHOULD OF BEEN CHECKED HEALTH PROFESSIONAL ON INITIAL REPORT. *NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): B6, G8, D7, D11,G8, H7, H9.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2018. RADIOGRAPHS SHOWED INCREASED PERI-HARDWARE LUCENCY, CONSISTENT WITH TIBIAL LOOSENING. PATIENT ALSO REPORTED ASSOCIATED LATERAL ANKLE PAIN. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND UNLIKELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240608 VANTAGE TIBIAL PLATE FB SZ 3 RT HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R