BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5905962 · Received August 26, 2016

    Report

    Report Number
    9614209-2016-00142
    Event Type
    Injury
    Date Received
    August 26, 2016
    Report Date
    October 10, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT ADDITIONAL INFORMATION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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. DEVICES NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, IT WAS NOT PROVIDED AND THUS THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. THE EXPLANTED DEVICES WERE NOT RETURNED TO CORIN FOR EXAMINATION, THEREFORE, IT CANNOT BE DETERMINED WHETHER THE CORIN CORMET DEVICES CAUSED OR CONTRIBUTED TO THE PATIENTS EXPERIENCE. BASED ON THIS, CORIN NOW CONSIDER THIS CASE CLOSED, HOWEVER, SHOULD THE EXPLANTS BECOME AVAILABLE OR IF ANY NEW INFORMATION IS PROVIDED, THIS CASE MAY 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CORMET REVISION DUE TO PAIN IN THE RIGHT HIP AND METAL REACTION.

    Description of Event or Problem · 1

    CORMET REVISION DUE TO PAIN IN THE RIGHT HIP AND METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557715 CORMET RESURFACING HIP PROSTHESIS NXT CORIN MEDICAL 180.30450 NRWG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization