BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 4620847 · Received April 1, 2014

    Report

    Report Number
    9614209-2014-00025
    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, RIGHT SIDE. DEVICE DETAILS, PATIENT 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 MANUFACTURING RECORDS CONFIRM THAT ALL MATERIAL AND DIMENSIONAL SPECIFICATIONS WERE MET FOR BOTH THE FEMORAL HEAD AND ACETABULAR CUP COMPONENTS. 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 OF RIGHT HIP AFTER 6 YEARS DUE TO ALVAL TYPE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197132 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN LTD. 114.062 0701688

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ASSOCIATED CORMET OPTIMOM HEAD (B)(4), LOT KCRE