BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMET RESURFACING

    MDR report key: 4092790 · Received September 2, 2014

    Report

    Report Number
    9614209-2014-00073
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CORIN LTD.
    Product Code
    NXT
    PMA / PMN Number
    P050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CANNOT BE REVIEWED AT THIS TIME AS NO DEVICE DETAILS HAVE BEEN PROVIDED FOR EITHER THE FEMORAL HEAD AND ACETABULAR CUP COMPONENTS.

    Description of Event or Problem · 1

    REVISION OF CORMET RESURFACING TO A TRINITY/METAFIX THR AFTER 7 YEARS 4 MONTHS DUE TO POSSIBLE ARMD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532025 CORMET RESURFACING METAL ON METAL RE-SURFACING NXT CORIN LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ASSOCIATED CORMET BI-COATED RESURFACING HEAD,| SIZE 48MM.