BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER FIT

    MDR report key: 4132028 · Received September 26, 2014

    Report

    Report Number
    9614209-2014-00083
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CORIN LTD.
    Product Code
    LZO
    PMA / PMN Number
    K003666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TO BE REVIEWED. 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

    A TAPEFIT CDH STEM HAS BROKEN AFTER 3 YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602212 TAPER FIT TOTAL HIP SYSTEM LZO CORIN LTD. E088.000 163043

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention