BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 5846204 · Received August 4, 2016

    Report

    Report Number
    9614209-2016-00133
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    July 6, 2016
    Report Date
    December 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K111481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS HAVE BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE RETRIEVED AND REVIEWED. THE INITIAL REPORTER TO CORIN (B)(4) HAS CONFIRMED THAT THE EXPLANTED DEVICES ARE NOT AVAILABLE TO BE RETURNED FOR EXAMINATION. 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. DEVICES NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, AND THE RETURN OF THE EXPLANTED DEVICES WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, HOWEVER, THESE WERE NOT PROVIDED AND THEREFORE THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. IT WAS FOUND THAT ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO CORIN AND THUS NO FURTHER INVESTIGATION CAN BE CONDUCTED. BASED ON THIS, CORIN NOW CONSIDER THIS CASE CLOSED. HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED, THIS CASE MAY 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 REVISION AFTER APPROXIMATELY 2 WEEKS DUE TO INFECTION.

    Description of Event or Problem · 1

    TRINITY REVISION AFTER APPROXIMATELY 2 WEEKS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498315 TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS LZO CORIN MEDICAL 104.3605 330568

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R