BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET, INC / EBI, LLC

    MDR report key: 2718837 · Received August 23, 2012

    Report

    Report Number
    MW5026654
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    May 2, 2010
    Report Date
    August 23, 2012
    Manufacturer
    BIOMET, INC
    Product Code
    ILO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT (B)(6) 2010, OUTPATIENT SURGERY WITH FUSION AND DEEP PERONEAL NERVE BURIAL OF RIGHT FOOT. PT WAS PROVIDED WITH COLD THERAPY UNIT KNOWN AS "BIOMET BIOCHILL" FROM EBI, LLC PRIOR TO DISCHARGE. INSTRUCTIONS WERE TO USE CONTINUOUSLY. ON (B)(6) 2010, PT NOTICED SIGNIFICANT PAIN AND CHILLS, PRESENTED TO LOCAL EMERGENCY DEPARTMENT WHERE NON-FREEZING COLD INJURY WAS SUSPECTED AND/OR COMPARTMENT SYNDROME. ATTEMPTS TO REVASCULARIZE THE FOOT WITH THROMBOLYTIC THERAPY, ANGIOPLASTY, AND USE OF A VASODILATOR WERE UNSUCCESSFUL. PT TOES 1-4 AND PART OF FOOT WERE AMPUTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET, INC / EBI, LLC BIOCHILL ILO BIOMET, INC 2001HB

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability