BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAFIX

    MDR report key: 5849525 · Received August 5, 2016

    Report

    Report Number
    9614209-2016-00028
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    December 7, 2015
    Report Date
    February 18, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JDI
    PMA / PMN Number
    K082525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP IN ERROR. THE INITIAL REPORTER TO CORIN CONFIRMED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO OPERATIVE TECHNIQUE, THEREFORE, THE EVENT DID NOT OCCUR DUE TO THE MALFUNCTION OR DETERIORATION OF A CORIN DEVICE. BASED ON THIS INFORMATION, CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, IF ANY FURTHER INFORMATION IS PROVIDED THIS CASE CAN BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    DURING A METAFIX OPERATION THE PATIENT'S FEMUR WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504487 METAFIX METAFIX HIP STEM JDI CORIN MEDICAL 340.440R NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization