BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5852803 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00024
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    October 10, 2014
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1194 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP IN ERROR. THIS CASE WAS SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS AND THE RETURN OF THE DEVICE WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NOT ALL WERE PROVIDED, THEREFORE, THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE NOT RECEIVED, THEREFORE THE RELEVANT DEVICE MANUFACTURING RECORDS FOR THE REPORTED DEVICE COULD NOT BE IDENTIFIED OR REVIEWED. THE REPORTED INSTRUMENT WAS NOT RETURNED TO CORIN (B)(4) FOR EXAMINATION, THUS A ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE IDENTIFIED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION COME TO LIGHT THIS CASE CAN BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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

    TRINITY CERAMIC/METAL LINER EXTRACTOR COULD NOT REMOVE THE CERAMIC LINER FROM THE SHELL. THE SURGEON HAD TO FRACTURE THE LINER IN ORDER TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507691 TRINITY ACETABULAR HIP SYSTEM LZO CORIN MEDICAL 921.143 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other