BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAFIX BROACH

    MDR report key: 4995928 · Received August 7, 2015

    Report

    Report Number
    9614209-2015-00040
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 9, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, PATIENT MEDICAL HISTORY AND EVENT DETAILS WERE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, HOWEVER, THESE WERE NOT ALL PROVIDED, THEREFORE, THERE WAS LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS AND DEVICE ITSELF WERE NOT PROVIDED TO CORIN, THEREFORE THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE RETRIEVED AND REVIEWED AND THE DEVICE COULD NOT BE EXAMINED. BASED ON THIS CORIN NOW CONSIDERS THIS CASE CLOSED. IF HOWEVER, NEW INFORMATION COMES TO LIGHT THIS CASE WILL 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, PATIENT MEDICAL HISTORY AND EVENT DETAILS WERE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, HOWEVER, THESE WERE NOT ALL PROVIDED, THEREFORE, THERE WAS LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS AND DEVICE ITSELF WERE NOT PROVIDED TO CORIN, THEREFORE THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE RETRIEVED AND REVIEWED AND THE DEVICE COULD NOT BE EXAMINED. BASED ON THIS CORIN NOW CONSIDERS THIS CASE CLOSED. IF HOWEVER, NEW INFORMATION COMES TO LIGHT THIS CASE WILL 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.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. DEVICE DETAILS, PATIENT MEDICAL HISTORY AND EVENT DETAILS HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED WHEN APPROPRIATE DEVICE INFO IS AVAILABLE. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN 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

    WHILST BROACHING TO IMPLANT A METAFIX STEM, THE FEMUR WAS FRACTURED DISTALLY. AS THE REMEDIAL ACTION REQUIRED IMPLANTATION OF A LONGER STEM THAT WAS NOT AVAILABLE AT THE TIME, THE SURGEON THEREFORE DECIDED TO CLOSE THE PATIENT, WITH ONLY THE CUP AND LINER IN SITU, AND IMPLANT A LONG REVISION PROSTHESIS WHEN AVAILABLE.

    Description of Event or Problem · 1

    WHILST BROACHING TO IMPLANT A METAFIX STEM, THE FEMUR WAS FRACTURED DISTALLY. AS THE REMEDIAL ACTION REQUIRED IMPLANTATION OF A LONGER STEM THAT WAS NOT AVAILABLE AT THE TIME, THE SURGEON THEREFORE DECIDED TO CLOSE THE PATIENT, WITH ONLY THE CUP AND LINER IN SITU, AND IMPLANT A LONG REVISION PROSTHESIS WHEN AVAILABLE.

    Description of Event or Problem · 1

    WHILST BROACHING TO IMPLANT A METAFIX STEM, THE FEMUR WAS FRACTURED DISTALLY. THE SURGEON THEREFORE DECIDED TO CLOSE THE PT, WITH ONLY THE CUP AND LINER IN SITU, AND TO IMPLANT A LONG REVISION PROSTHESIS WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521281 METAFIX BROACH FEMORAL BROACH INSTRUMENT LZO CORIN MEDICAL 340.338 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R