BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5853718 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00107
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    February 3, 2016
    Report Date
    August 10, 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. 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 EXPLANTED DEVICES WERE RETURNED TO CORIN UK FOR REVIEW. THE EXAMINATION OF THE RETURNED EXPLANTS COULD NOT IDENTIFY A SPECIFIC REASON FOR REVISION, ANY OBVIOUS FAILURE MODES OR ABNORMAL DEVICE CHARACTERISTICS. THE CORIN DEVICES WERE COUPLED WITH A TAPER CONVERSION SLEEVE (MANUFACTURER UNKNOWN), WHICH EXHIBITED EVIDENCE OF CORROSION INSIDE IT. BASED ON THIS, IT CANNOT BE DETERMINED WHETHER THE CORIN CORMET DEVICES CAUSED OR CONTRIBUTED TO THE PATIENTS EXPERIENCE AND CORIN NOW CONSIDERS THIS CASE CLOSED. 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 THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. THE REPORTED EXPLANTS HAVE BEEN RECEIVED AT CORIN AND WILL BE REVIEWED AND INFORMATION PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THIS 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 12 YEARS DUE TO PAIN AND ELEVATED COBALT AND CHROMIUM ION LEVELS.

    Description of Event or Problem · 1

    CORMET REVISION AFTER APPROXIMATELY 12 YEARS DUE TO PAIN AND ELEVATED COBALT AND CHROMIUM ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506872 CORMET RESURFACING HIP PROSTHESIS NXT CORIN MEDICAL 179.250B IDCE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization