BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AIM DYNAMIC TIBIA NAIL

    MDR report key: 6960046 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-09204
    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 WHO UNDERWENT A TIBIAL LENGTHENING PROCEDURE UTILIZING AN INTRAMEDULLARY NAIL AND EXTERNAL FIXATOR, EXPERIENCED ANKLE JOINT EQUINUS CONTRACTURE, AND UNDERWENT AN ACHILLES TENDON LENGTHENING AND POSTERIOR CAPSULOTOMY AT 6 MONTHS POSTOPERATIVELY BECAUSE THE COMPLICATION DID NOT RESPOND TO CLOSED TREATMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737726 UNKNOWN AIM DYNAMIC TIBIA NAIL FIXATION, NAIL HSB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R