BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 4574769 · Received May 16, 2014

    Report

    Report Number
    9614209-2014-00048
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    November 26, 2013
    Report Date
    May 15, 2014
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. DEVICE DETAILS, PT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MFG RECORDS TO BE REVIEWED. THIS REPORT IS FILED WITH THE FDA DUE TO AN 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 4 YEARS 5 MONTHS DUE TO ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295395 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN MEDICAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention ASSOCIATED CORMET HEAD 189.048B, LOT MXGC.