BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5849457 · Received August 5, 2016

    Report

    Report Number
    9614209-2016-00015
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    October 13, 2011
    Report Date
    August 8, 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). PLEASE NOTE: THIS MDR WAS ORIGINALLY FILED ON (B)(6) 2016 TO AN ESUBMISSIONS TEST ACCOUNT. THIS CASE IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, 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. UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE RETRIEVED 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 AND THESE DEVICES ARE NO LONGER AVAILABLE TO ANY MARKET.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, IT WAS NOT PROVIDED. THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE DEVICE AND THE DEVICE DETAILS WERE NOT PROVIDED TO CORIN, THUS, THE DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED AND REVIEWED AND THE DEVICES THEMSELVES COULD NOT BE EXAMINED. BASED ON THIS, IT CANNOT BE DETERMINED AT THIS TIME WHETHER THE CORIN DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION BE 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

    CORMET REVISION AFTER APPROXIMATELY 6 YEARS DUE TO METALOSIS.

    Description of Event or Problem · 1

    CORMET REVISION AFTER APPROXIMATELY 6 YEARS DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501686 CORMET HIP RESURFACING PROSTHESIS NXT CORIN MEDICAL NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization