BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5849649 · Received August 5, 2016

    Report

    Report Number
    9614209-2016-00069
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    November 3, 2014
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1213 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THIS CASE WAS SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. THE INITIAL REPORTER TO CORIN UK CONFIRMED THAT THE PATIENT WAS NOT AFFECTED BY THIS EVENT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. THE DEVICE WAS EXAMINED AT CORIN UK AND THE REPORTED FAILURE MODE WAS VERIFIED, A POSSIBLE ROOT CAUSE COULD HAVE BEEN DUE TO CROSS THREADING. CORIN HAVE NOW INITIATED A PROJECT TO REVIEW THE DESIGN OF THESE INSTRUMENTS. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED. 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

    DURING SURGERY THE CUP GOT STUCK TO THE TRINITY STD INTRODUCER / IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504347 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.129 188526-05

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown