BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 17371408 · Received July 21, 2023

    Report

    Report Number
    9614209-2023-00209
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 27, 2023
    Report Date
    February 15, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LZO
    PMA / PMN Number
    K122305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CASE-(B)(4) FINAL REPORT ADDITIONAL INFORMATION INCLUDING; PHOTOS HIGHLIGHTING THE FAILURE, IF THE CORRESPONDING IMPACTOR IS AVAILABLE FOR RETURN AND THE DEVICE DETAILS FOR THE CORRESPONDING IMPACTOR WERE REQUESTED BUT NOT PROVIDED. THE SHELL DEVICE DETAILS WERE PROVIDED AND THE MANUFACTURING RECORDS SHOWED THAT THE ACETABULAR SHELL WAS MANUFACTURED 6 WEEKS BEFORE THE REPORTED EVENT AND CONFORMED TO SPECIFICATION AT THE TIME OF MANUFACTURE. THE IMPACTOR HANDLE PART NUMBER WAS PROVIDED BUT THE LOT CODE WAS NOT. THE DEVICES WERE NOT RETURNED TO CORIN. THIS FAILURE MODE HAS BEEN REPORTED TO CORIN PREVIOUSLY, AND A DESIGN CHANGE TO THE IMPACTOR HANDLE IS BEING IMPLEMENTED. THE IMPACTOR HANDLE REPORTED IN THIS EVENT WAS MANUFACTURED PRIOR TO THIS DESIGN CHANGE. THIS CASE IS NOW CONSIDERED CLOSED. IF ADDITIONAL INFORMATION IS PROVIDED, THE CASE MAY BE RE-OPENED. 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; PHOTOS HIGHLIGHTING THE FAILURE, IF THE CORRESPONDING IMPACTOR IS AVAILABLE FOR RETURN AND THE DEVICE DETAILS FOR THE CORRESPONDING IMPACTOR HAS 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 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION INCLUDING; PHOTOS HIGHLIGHTING THE FAILURE, IF THE CORRESPONDING IMPACTOR IS AVAILABLE FOR RETURN AND THE DEVICE DETAILS FOR THE CORRESPONDING IMPACTOR WERE REQUESTED BUT NOT PROVIDED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE MANUFACTURING RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED 6 WEEKS BEFORE THE REPORTED EVENT AND CONFORMED TO SPECIFICATION AT THE TIME OF MANUFACTURE. THE DEVICE WAS NOT RETURNED TO CORIN, AND WITH THE INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED. THE FAILURE MODE IS NOT CONFIRMED AND THE ROOT CAUSE IS NOT DETERMINED. THIS CASE IS NOW CONSIDERED CLOSED. IF ADDITIONAL INFORMATION IS PROVIDED, THE CASE MAY BE RE-OPENED. 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

    TRINITY-I SHELL WOULD NOT DISENGAGE FROM THE IMPACTOR HANDLE FOLLOWING IMPACTION

    Description of Event or Problem · 0

    TRINITY-I SHELL WOULD NOT DISENGAGE FROM THE IMPACTOR HANDLE FOLLOWING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255938 TRINITY TRINITY ACETABULAR SYSTEM LZO CORIN LTD 321.03.350 527660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other TRINITY IMPACTOR HANDLE, 921.129, LOT UNKNOWN.