BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET

    MDR report key: 5856003 · Received August 9, 2016

    Report

    Report Number
    9614209-2015-00079
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    May 30, 2012
    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. THE INITIAL REPORTER TO CORIN CONFIRMED THAT THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT A CORIN DEVICE. THUS CORIN CLOSES ITS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS AND THE REASON FOR REVISION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. 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

    PREVIOUSLY REPORTED AS "CORMET REVISION AFTER APPROXIMATELY 7 YEARS. THE REASON FOR REVISION IS UNKNOWN." THE INITIAL REPORTER HAS SINCE REPORTED TO CORIN THAT THE DEVICE WAS NOT A CORIN PRODUCT.

    Description of Event or Problem · 1

    CORMET REVISION AFTER APPROXIMATELY 5 YEARS. THE REASON FOR REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507745 CORMET CORMET HIP RESURFACING SYSTEM NXT CORIN MEDICAL NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization