BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5853060 · Received August 8, 2016

    Report

    Report Number
    9614209-2015-00085
    Event Type
    Injury
    Date Received
    August 8, 2016
    Report Date
    August 8, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE REVISION X-RAYS, REASON FOR REVISION AND THE EXPLANTS WERE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, HOWEVER, NOT ALL WERE PROVIDED, THEREFORE, THERE WAS LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE 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 EXPLANTS WERE EXAMINED AT CORIN. THE CORIN DEVICES HAD BEEN COUPLED WITH A NON-CORIN TAPER ADAPTER SLEEVE. AT THIS TIME IT CANNOT BE DETERMINED WHETHER THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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 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. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE REVISION X-RAYS, REASON FOR REVISION AND RETURN OF THE EXPLANTS 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 RELEVANT DEVICE MANUFACTURING RECORDS WILL BE RETRIEVED AND REVIEWED UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS. 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 DUE TO ELEVATED COBALT AND CHROMIUM LEVELS AND PAIN. THE LENGTH OF TIME THAT THE DEVICES WERE IMPLANTED IS UNKNOWN.

    Description of Event or Problem · 1

    CORMET REVISION, BOTH THE REASON FOR REVISION AND THE PERIOD OF TIME IN WHICH THE DEVICES WERE IMPLANTED ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504836 CORMET RESURFACING HIP PROSTHESIS NXT CORIN MEDICAL 179.254B HGCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization