BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AIM DYNAMIC TIBIA NAIL

    MDR report key: 6960060 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-09207
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    April 16, 2008
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT - PUBLICATION DATE OF ARTICLE. HAYOUNG KIM, SANG KI LEE, KAP JUNG KIM, JAE HOON AHN, WON SIK CHOY, YONG IN KIM, AND JEA YUN KOO ¿TIBIAL LENGTHENING USING A REAMED TYPE INTRAMEDULLARY NAIL AND AN ILIZAROV EXTERNAL FIXATOR¿. INTERNATIONAL ORTHOPAEDICS (SICOT) (2009) 33:835-841. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE (1) PATIENT COMPLAINED OF PARAESTHESIA OF THE PLANTAR ASPECT OF THE ASSOCIATED FOOT, FOLLOWING A TIBIAL LENGTHENING PROCEDURE UTILIZING AN INTRAMEDULLARY NAIL AND EXTERNAL FIXATOR. THIS REPORTEDLY RESOLVED BY THREE (3) MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737727 UNKNOWN AIM DYNAMIC TIBIA NAIL FIXATION, NAIL HSB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other