BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFIT TS

    MDR report key: 4864941 · Received June 18, 2015

    Report

    Report Number
    9614209-2015-00031
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 18, 2015
    Manufacturer
    CORIN LTD, THE CORINIUM CENTRE
    Product Code
    MEH
    PMA / PMN Number
    K121563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT: 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 WILL BE REVIEWED ONCE THE DEVICE DETAILS HAVE BEEN PROVIDED TO CORIN LTD.

    Description of Event or Problem · 1

    REVISION OF A TRIFIT TS STEM AND ASSOCIATED TRINITY MODULAR HEAD AFTER 44 DAYS DUE TO A REPORTED UNDERSIZING OF THE STEM COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398100 TRIFIT TS NON-CEMENTED HIP STEM PROSTHESIS MEH CORIN LTD, THE CORINIUM CENTRE 694.0005 303384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT DETAILS NOT PROVIDED