BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5846464 · Received August 4, 2016

    Report

    Report Number
    9614209-2016-00002
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    July 17, 2013
    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). INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING PATIENT MEDICAL HISTORY, A DETAILED PATIENT OUTCOME AND THE EXPLANTS HAVE 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 HAVE BEEN RETRIEVED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. 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). FINAL REPORT. ADDITIONAL INFORMATION AND THE EXPLANT WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, THESE WERE NOT ALL PROVIDED, THEREFORE, THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. X-RAY WERE PROVIDED AND REVIEWED. DEVICE MANUFACTURING RECORDS WERE RETRIEVED AND REVIEWED AND IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THE RECORDS CONFORMED TO SPECIFICATION WHEN MANUFACTURED. THE INITIAL REPORTER TO CORIN CONFIRMED THAT THE EXPLANTS WERE NOT AVAILABLE TO RETURN FOR EXAMINATION, SO AT THIS TIME, WE CANNOT DETERMINE WHETHER THE REPORTED DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THE CORIN DEVICES WERE COUPLED WITH A NON-CORIN TAPER ADAPTER SLEEVE. CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD FURTHER INFORMATION BECOME AVAILABLE, IT CAN BE REOPENED 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 8 YEARS AND 7 MONTHS DUE TO METAL-ON-METAL REACTION.

    Description of Event or Problem · 1

    CORMET REVISION AFTER APPROXIMATELY 8 YEARS AND 7 MONTHS DUE TO METAL-ON-METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498442 CORMET HIP RESURFACING PROSTHESIS NXT CORIN MEDICAL 179.248B IHRV

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization