BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 22803846 · Received August 14, 2025

    Report

    Report Number
    9614209-2025-00558
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    May 15, 2025
    Report Date
    March 24, 2026
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    UDI-DI
    05055343865224
    PMA / PMN Number
    K110087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT: ADDITIONAL INFORMATION INCLUDING THE DEVICE LOT CODE AND THE PART NO. AND LOT CODE OF THE ASSOCIATED CUP WAS REQUESTED FROM THE REPORTER. THIS INFORMATION HAS NOT BEEN PROVIDED AND THE DEVICES HAVE NOT BEEN RETURNED TO CORIN UK. THE APPROPRIATE DEVICE DETAILS HAVE NOT BEEN PROVIDED AND THUS THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED AND REVIEWED. AS THE DEVICES HAVE NOT BEEN RETURNED AND LOT CODES NOT PROVIDED NO INVESTIGATION CAN BE PERFORMED, AND THE REPORTED MALFUNCTION COULD NOT BE VERIFIED. THE ROOT CAUSE IS UNKNOWN, AND THIS CASE IS NOW CONSIDERED CLOSED. HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED OR DEVICES THEN THIS CASE CAN BE RE-OPENED FOR 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING THE DEVICE LOT CODE AND THE PART NO. AND LOT CODE OF THE ASSOCIATED CUP HAS BEEN REQUESTED FROM THE REPORTER, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE REPORTED DEVICES ARE BEING RETURNED AND WILL BE EXAMINED. UPON RECIEPT OF THE APPROPRIATE DEVICE DETAILS, THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    CORIN WERE INITIALLY INFORMED ON 15 MAY 2025 THAT DURING SURGERY THE TRINITY STD INTRODUCER / IMPACTOR HANDLE BECAME JAMMED WITH THE CUP DUE TO A LOOSE HANDLE. BASED ON THE INITIAL DETAILS PROVIDED, THIS EVENT WAS NOT CONSIDERED REPORTABLE. CORIN RECEIVED ADDITIONAL INFORMATION FROM THE REPORTER ON 23 JUL 2025 THAT DEEMED THIS EVENT REPORTABLE. IT WAS STATED THAT THE CUP HAD NOT REMAINED IMPLANTED AS ORIGINALLY THOUGHT. THE HANDLE AND CUP COULD NOT BE SEPARATED AFTER MULTIPLE ATTEMPTS AND THUS THE IMPACTED CUP WAS REMOVED FROM THE PATIENT'S ACETABULUM, AND AN ALTERNATIVE HANDLE AND CUP WERE LOCATED AND USED.

    Description of Event or Problem · 0

    CORIN WERE INITIALLY INFORMED ON (B)(6) 2025 THAT DURING SURGERY THE TRINITY STD INTRODUCER / IMPACTOR HANDLE BECAME JAMMED WITH THE CUP DUE TO A LOOSE HANDLE. BASED ON THE INITIAL DETAILS PROVIDED, THIS EVENT WAS NOT CONSIDERED REPORTABLE. CORIN RECEIVED ADDITIONAL INFORMATION FROM THE REPORTER ON 23 JUL 2025 THAT DEEMED THIS EVENT REPORTABLE. IT WAS STATED THAT THE CUP HAD NOT REMAINED IMPLANTED AS ORIGINALLY THOUGHT. THE HANDLE AND CUP COULD NOT BE SEPARATED AFTER MULTIPLE ATTEMPTS AND THUS THE IMPACTED CUP WAS REMOVED FROM THE PATIENT'S ACETABULUM, AND AN ALTERNATIVE HANDLE AND CUP WERE LOCATED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568654 TRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS (STD INTRODUCER / IMPACTOR HANDLE) LZO CORIN LTD 921.129G NOT PROVIDED 05055343865224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY CUP: DEVICE DETAILS UNKNOWN.| TRINITY CUP: DEVICE DETAILS UNKNOWN.