BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 4574785 · Received May 16, 2014

    Report

    Report Number
    9614209-2014-00051
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    January 31, 2013
    Report Date
    May 14, 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) COMBINED INITIAL AND FINAL REPORT. DEVICE DETAILS, PT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. HOWEVER, NOT ALL THESE WERE MADE AVAILABLE FOR THE INVESTIGATION. DEVICE MFG RECORDS CONFIRMED THAT ALL MATERIAL AND DIMENSIONAL SPEC WERE MET FOR BOTH THE FEMORAL HEAD AND ACETABULAR CUP COMPONENTS. 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 OPTIMOM REVISION AFTER 6 1/2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295152 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN MEDICAL, LTD. 179.254B JZND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ASSOCIATED OPTIMOM MODULAR HEAD E079.048, LOT JTTI