BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKLE TIBIAL INSERT

    MDR report key: 9428453 · Received December 6, 2019

    Report

    Report Number
    1818910-2019-121629
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    January 1, 2013
    Report Date
    November 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL EXAMINATION OF THE PROVIDED X-RAY IMAGES CONFIRMED THE REPORTED EVENT. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED ¿USE OF FEMORAL LOCKING PLATE FOR SALVAGE OF FAILED ANKLE ARTHROPLASTY AFTER TRAUMA¿ WRITTEN BY LAWRENCE A. DIDOMENICO, DPM, FACFAS, ET AL; PUBLISHED IN THE JOURNAL OF FOOT AND ANKLE SURGERY, IN 2013, 52, 397-401; WAS REVIEWED. THIS ARTICLE REPORTS ON A CASE STUDY OF A 45-YEAR-OLD WOMAN WITH A MEDICAL HISTORY OF GOUT, CANCER, HEART DISEASE, HYPERTENSION, FOOT AND LEG CRAMPING, VARICOSE VEINS AND POST-TRAUMATIC ARTHRITIS PRESENTED WITH A CHIEF CHRONIC COMPLAINT OF ANKLE PAIN THAT HAD WORSENED DURING A SIX-MONTH PERIOD. SHE RELATED A VAST HISTORY OR FRACTURES AND RECURRENT SPRAINS TO HER LEFT ANKLE. CONSERVATIVE MEASURES WERE ATTEMPTED FOR TWO YEARS UNTIL SHE FINALLY UNDERWENT A TOTAL ANKLE PROSTHESIS, AGILITY, LP TOTAL ANKLE SYSTEM (DEPUY), GASTROCNEMIUS RECESSION, AND MIDFOOT FUSION. THE PATIENT EXPERIENCED A STABLE, NON-SYMPTOMATIC PSEUDO-ARTHRITIS OF THE TIBIOFIBULAR JOINT. THIS CONSTRUCT PROVED TO BE SATISFACTORY FOR FIVE YEARS, UNTIL THE PATIENT FELL DOWN THE STEPS. AFTER THE ACCIDENT, RADIOGRAPHS REVEALED THE TALAR COMPONENT HAD BEEN ANTERIORLY DISPLACED AND ROTATED. THE PSEUDO-ARTHRITIS DEMONSTRATED NO CHANGES, WIDENING OR INSTABILITY; THUS IT WAS BELIEVED TO BE UNRELATED TO THE TRAUMA. THE PATIENT ALSO SHOWED SIGNS OF TENDERNESS AND SWELLING OF THE LEFT ANKLE. SHE WAS PAIN FREE WITH ROM TO THE SUBTALAR JOINT. AN ATTEMPTED REVISION PROVED TO NOT BE POSSIBLE, AND THE TOTAL ANKLE ARTHROPLASTY WAS REMOVED, AND ANKLE FUSION WAS PERFORMED USING AN ANTERIOR ANKLE ARTHRODESIS LOCKING PLATE (MANUFACTURER NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225449 UNKNOWN ANKLE TIBIAL INSERT ANKLE TIBIAL INSERT HSN DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention