BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAFIX

    MDR report key: 5852782 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00060
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JDI
    PMA / PMN Number
    K082525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1163 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THIS CASE WAS SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION AND THE RETURN OF THE REPORTED DEVICES WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, THESE WERE NOT PROVIDED. THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. THE REPORTED DEVICES WERE NOT RETURNED TO CORIN UK FOR EXAMINATION, THEREFORE, AN INVESTIGATION COULD NOT BE CARRIED OUT ON THE FEMORAL NECKS OR THE ASSOCIATED BROACH. CORIN CANNOT CONCLUSIVELY STATE WHETHER THE TRIAL NECKS OR BROACH WERE AT FAULT IN THIS INSTANCE. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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

    METAFIX BROACH CAN NO LONGER HAVE THE TRIAL NECK CONNECTED TO IT AS THE CONNECTOR APPEARS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507688 METAFIX HIP STEM JDI CORIN MEDICAL 340.433R 276481-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown