BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER METAPHYSEAL-DIAPHYSEAL NAIL

    MDR report key: 6737201 · Received July 24, 2017

    Report

    Report Number
    0001822565-2017-05139
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    April 16, 2008
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER, 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)(6). 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.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE REMAINS UNDETERMINED.

    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, COMPLAINED OF LOWER BACK PAIN, HOWEVER THIS SYMPTOM IMPROVED AFTER COMPLETING LIMB LENGTHENING AND REMOVING THE EXTERNAL FIXATOR FRAME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517314 UNKNOWN ZIMMER METAPHYSEAL-DIAPHYSEAL NAIL FIXATION, NAIL HSB ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other