BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE

    MDR report key: 8449398 · Received March 25, 2019

    Report

    Report Number
    1038671-2019-00180
    Event Type
    Injury
    Date Received
    March 25, 2019
    Report Date
    January 13, 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). (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT : ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (B5) AS REPORTED, IN (B)(6) 2019, THE 77 Y/O MALE PATIENT¿S RIGHT ANKLE WAS NOTED AS COLLAPSED BACK INTO VARUS ANGULATION. IT IS NOTED AS RESOLVED IN (B)(6) 2019. THE PATIENT WEIGHS180 LBS. AND HEIGHT IS 5¿4¿. THE INITIAL IMPLANT ON R ANKLE WAS ON (B)(6) 2018.THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS, HEART DISEASE, DIABETES, PARKINSON¿S DISEASE, AND GALLBLADDER CANCER. THE PATIENT HAS ALSO RECEIVED CORTICOSTEROID INJECTIONS. THE PATIENT USES A CANE FOR AMBULATION AND HAS BEEN INSTRUCTED ON STRETCHING EXERCISES. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. (D4) UNIQUE IDENTIFIER (UDI) #: (B)(4). (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K152217. (H3) AS REPORTED, IN (B)(6) 2019, THE 77 Y/O MALE PATIENT¿S THE ANKLE WAS NOTED AS COLLAPSED BACK INTO VARUS ANGULATION. IT IS NOTED AS RESOLVED IN(B)(6) 2019. THE PATIENT WEIGHS180 LBS. AND HEIGHT IS 5¿4¿. THE INITIAL IMPLANT ON R ANKLE WAS ON (B)(6) 2018.THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS, HEART DISEASE, DIABETES, PARKINSON¿S DISEASE, AND GALLBLADDER CANCER. THE PATIENT HAS ALSO RECEIVED CORTICOSTEROID INJECTIONS. THE PATIENT USES A CANE FOR AMBULATION AND HAS BEEN INSTRUCTED ON STRETCHING EXERCISES. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. ACCORDING TO IFU# 700-096-157 REV. 1 - PATIENTS SHOULD BE INSTRUCTED ON THE LIMITATIONS OF THE PROSTHESIS AND THE POSSIBILITY OF SUBSEQUENT SURGERY. THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. PATIENTS SHOULD BE WARNED TO PROTECT THE JOINT REPLACEMENT FROM UNREASONABLE STRESSES AND TO FOLLOW THE TREATING PHYSICIAN¿S INSTRUCTIONS, UNTIL ANTERIOR WOUND HEALING IS COMPLETE. THIS DEVICE IS USED FOR TREATMENT AND NOT DIAGNOSIS. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT PAIN, INFECTION, LOOSENING OF TOTAL JOINT HARDWARE AND THE PATIENT SHOULD MONITOR THEIR ACTIVITY AND STRESSES TO THE OPERATED ANKLE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE PATIENT¿S CONDITIONS. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (G3) REPORT SOURCE: HEALTH PROFESSIONAL.

    Description of Event or Problem · 0

    AS REPORTED, IN (B)(6) 2019, THE 77 Y/O MALE PATIENT¿S RIGHT ANKLE WAS NOTED AS COLLAPSED BACK INTO VARUS ANGULATION. IT IS NOTED AS RESOLVED IN (B)(6) 2019. THE PATIENT WEIGHS180 LBS. AND HEIGHT IS 5¿4¿. THE INITIAL IMPLANT ON R ANKLE WAS ON (B)(6) 2018.THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS, HEART DISEASE, DIABETES, PARKINSON¿S DISEASE, AND GALLBLADDER CANCER. THE PATIENT HAS ALSO RECEIVED CORTICOSTEROID INJECTIONS. THE PATIENT USES A CANE FOR AMBULATION AND HAS BEEN INSTRUCTED ON STRETCHING EXERCISES. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2018. COLLAPSE OF ANKLE BACK INTO VARUS ANGULATION. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240793 VANTAGE TIBIAL PLATE FB SZ 3 RT HSN EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R