BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FIT FEMORAL STEM

    MDR report key: 49067 · Received November 7, 1996

    Report

    Report Number
    1056629-1996-09002
    Event Type
    Malfunction
    Date Received
    November 7, 1996
    Date of Event
    July 1, 1996
    Report Date
    November 6, 1996
    Manufacturer
    CORIN MEDICAL LTD
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO WAS ADVISED ON 11/1/96, THAT PT HAD BEEN INVOLVED IN A CAR ACCIDENT, SOMTIME IN 6/96. SUBSEQUENT X-RAYS SHOW THE HIP IMPLANT TO HAVE A TRANSVERSE FRACTURE, WHICH WILL REQUIRE REVISIONL THIS IS A FLUKE OCCURRENCE BUT REPORTABLE NEVERTHELESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FIT FEMORAL STEM Implant CEMENTED HIP STEM KWY CORIN MEDICAL LTD NA ARXW

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization