BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN

    MDR report key: 428761 · Received November 18, 2002

    Report

    Report Number
    MW1026775
    Event Type
    Injury
    Date Received
    November 18, 2002
    Date of Event
    April 19, 2002
    Report Date
    November 18, 2002
    Manufacturer
    CORIN LTD
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/23/02: A RECENT TIMES NEWSPAPER SUPPLEMENTAL ON THE UK MEDICAL PROFESSION AND ORTHOPAEDICS IN PARTICULAR, LISTED 99 UK HOSPITALS HAVING ORTHOPAEDICS DEPARTMENTS. SO FAR, RPTR HAS TRACED FIVE HOSPITALS WHO HAVE DISCONTINUED USING THE C-FIT BECAUSE OF STEM FRACTURING. THE MEDICAL DEVICES AGENCY (MDA) INVESTIGATION HAS DETERMINED THAT A SMALL NUMBER OF IMPLANT FRACTURES HAVE BEEN OBSERVED AT TWO CENTRES IN THE UK. THE MFR HAS ADVISED THE MDA THAT THEY HAVE DISTRIBUTED SOME 12,000 DEVICES OF THIS TYPE WORLDWIDE AND ARE UNAWARE OF ANY OTHER REPORTS OF BREAKAGE. IN ADDITION, A CLINICAL STUDY ON THE C-FIT HAS BEEN PERFORMED AT A THIRD CENTRE, WHERE OUT OF SOME 540 IMPLANT OPERATIONS OVER A SIX YEAR PERIOD, 99.8% OF THE IMPLANTS REMAINED FUNCTIONAL TO SIX YEARS IMPLANTATION TIME. THE RESULTS OF THIS STUDY FALL WITHIN THE RECOMMENDATION FROM THE NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE AS ACCEPTABLE REVISION RATES FOR HIP REPLACEMENT IMPLANTS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/23/02: 1. THE MODEL NUMBER OF THE DEVICE IS 124.110. 2. THE MANUFACTURING LOT IS 36305, 224/3. CORIN HAS NOT PREVIOUSLY SUBMITTED A MEDWATCH FORM REPORTING THIS EVENT. CO IS NOT AWARE OF ANY PRIOR FAILURES OF THIS DEVICE IN THE U.S.A.

    Description of Event or Problem · 1

    PT WAS FITTED WITH A C-FIT ARTIFICIAL HIP JOINT MANUFACTURED BY THE CORIN GROUP. PT ENGAGE IN NO SPORTING ACTIVITIES. EXACTLY FIVE YEARS AFTER INITIAL FITMENT, THE STEM OF THE PROSTHESIS FRACTURED WHERE THE ROUND STEM MEETS THE HEAD OF THE PROSTHESIS. THE INITIAL SURGEON CARRIED OUT THE REVISED SURGERY AND ADVISED THAT PT WAS HIS SEVENTH PT TO PRESENT WITH A FRACTURED/SNAPPED STEM IN EXACTLY THE SAME PLACE. X-RAYS AVAILABLE. THE HOSP NO LONGER USES THE C-FIT. PT REQUIRES INFO FROM THE F.D.A. AS TO THE RELIABILITY OF THE C-FIT IN AMERICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORIN ARTIFICIAL HIP JOINT -COLLARED- JDI CORIN LTD 124.110 36305, 224/3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R