BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 23049518 · Received September 15, 2025

    Report

    Report Number
    9614209-2025-00578
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 27, 2025
    Report Date
    November 21, 2025
    Manufacturer
    CORIN LTD
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER (B)(4) FINAL REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE REOCRDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THIS FAILURE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND AS A RESULT OF FEEDBACK, A NEW HANDLE HAS BEEN RELEASED AND THUS THIS CASE IS CONSIDERED CLOSED. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE REPORTING ENTITIES REPRESENTITIVE OR DISTRUBUTERCAUSED OR CONTRIBUTED TO THIS EVENT. 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.

    Additional Manufacturer Narrative · 0

    PER (B)(4) INITIAL REPORT. THE REPORTER HAS CONFIRMED THE DEVICE IS AVAILABLE FOR RETURN. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED, AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE REPORTING ENTITIES REPRESENTATIVE OR DISTRIBUTER CAUSED OR CONTRIBUTED TO THIS EVENT 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 · 0

    TRINITY STD INTRODUCER / IMPACTOR HANDLE: GOT STUCK ON THE CUP INTRA-OP. CUP REMOVED FROM ACETABULUM AND SURGEON REAMED UP AND IMPLANTED NEW CUP.SMALL DELAY TO SURGERY.

    Description of Event or Problem · 0

    TRINITY STD INTRODUCER / IMPACTOR HANDLE: GOT STUCK ON THE CUP INTRA-OP. CUP REMOVED FROM ACETABULUM AND SURGEON REAMED UP AND IMPLANTED NEW CUP. SMALL DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061675 TRINITY ACETABULAR HIP SYSTEM (STD INTRODUCER/ IMPACTOR HANDLE) LWJ CORIN LTD 921.129G 087074-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY CUP: 321.03.353, 588793.