BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONICARE MODEL BIO-1000 SYSTEM

    MDR report key: 3068304 · Received October 30, 2006

    Report

    Report Number
    3003920777-2006-00001
    Event Type
    Injury
    Date Received
    October 30, 2006
    Date of Event
    January 14, 2006
    Report Date
    December 1, 2006
    Manufacturer
    BIONICARE MEDICAL TECHNOLOGIES, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMERCIAL DISTRIBUTION OF BIONICARE PRODUCTS COMMENCED IN (B)(4) 2003. BIONICARE HAS NEVER RECEIVED ANY CUSTOMER COMPLAINTS FROM ANY SOURCE RELATED TO PULMONARY EMBOLISM. SINCE COMMENCEMENT OF COMMERCIAL OPERATIONS IN (B)(4) 2003 APPROX 30,000 PATIENTS HAVE USED THE BIONICARE KNEE DEVICE, ACCOUNTING FOR AN ESTIMATED 7- 8 MILLION HOURS OF CUMULATIVE DEVICE USE HISTORY. THE INCIDENCE OF PULMONARY EMBOLUS IN THE GENERAL POPULATION IS APPROXIMATELY 1.6 PER THOUSAND.

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED WITH DIAGNOSIS OF PULMONARY EMBOLISM COINCIDENTAL TO USE OF THE BIONICARE KNEE DEVICE. PATIENT WAS DISCHARGED 4 DAYS LATER AND PLACED ON COUMADIN (WARFARIN). THE TREATING PHYSICIAN INDICATED THAT THE PATIENT SHOULD REMAIN ON COUMADIN FOR THE REMAINDER OF HER LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONICARE MODEL BIO-1000 SYSTEM BIONICARE KNEE DEVICE GZJ BIONICARE MEDICAL TECHNOLOGIES, INC. BIO-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| S