BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 4620846 · Received April 1, 2014

    Report

    Report Number
    9614209-2014-00022
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 1, 2014
    Manufacturer
    CORIN 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. PATIENT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE NOT YET BEEN PROVIDED. THE DEVICE MANUFACTURING RECORDS WILL BE REVIEWED ON DUE COURSE. PLEASE NOTE: 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 5 YEARS DUE TO ALVAL TYPE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197044 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN LTD. 179.248B LDHT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ASSOCIATED CORMET MODULAR HEAD (B)(4), LOT LEXZ