BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5913854 · Received August 30, 2016

    Report

    Report Number
    9614209-2016-00149
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 9, 2016
    Report Date
    October 13, 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 REASON FOR REVISION AND OPERATIVE NOTES 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 WILL BE IDENTIFIED AND REVIEWED. THE EXPLANTED DEVICES HAVE BEEN RETURNED TO CORIN AND WILL BE EXAMINED. 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

    PATIENT X-RAYS AND THE EXPLANTED DEVICES WERE PROVIDED TO AID THE INVESTIGATION AND WERE REVIEWED AT CORIN. OPERATIVE NOTES AND THE REASON FOR REVISION WERE NOT AVAILABLE. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. IT WAS FOUND THAT ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. THE EXPLANTED DEVICES WERE RETURNED FOR EXAMINATION. 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. 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 11 YEARS AND 5 MONTHS. THE REASON FOR REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    CORMET REVISION AFTER APPROXIMATELY (B)(6). THE REASON FOR REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566217 CORMET HIP RESURFACING SYSTEM NXT CORIN MEDICAL 179.250B 030269

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R