BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCOX TOTAL HIP SYSTEM

    MDR report key: 18107994 · Received November 9, 2023

    Report

    Report Number
    3009106092-2023-00002
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 9, 2023
    Manufacturer
    CORENTEC CO.,LTD.
    Product Code
    LPH
    UDI-DI
    08806373830600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    2EA METAL HEADS SHIPPED TO THE U.S. WERE LABELED 28S, BUT THE ACTUAL PRODUCT WAS PACKAGED IN A SIZE OF 28M. IN ORDER TO DETERMINE THE CAUSE, WE TRACKED IT BASED ON THE LOT NUMBER AND FOUND THAT THE PRODUCTS OF 2EA IN SIZE 28M AND SIZE 28S WERE PACKAGED ON THE SAME DATE. CORENTEC SHALL RETRIEVE THE PRODUCT FROM A HOSPITAL, SURGEON, PATIENT OR OTHER PLACE OF SALE TO ENSURE APPROPRIATE ACTION IS TAKEN IN ACCORDANCE WITH CUSTOMER COMPLAINT MANAGEMENT STANDARD (CRSI-07-14) AND MEDICAL DEVICE REPORTING STANDARD (CRSI-07-13). TO THIS END, WE TRACKED 2EA PRODUCTS SHIPPED TO THE UNITED STATES. AFTER TRACKING THE USE OF THE PRODUCTS, BOTH PRODUCTS WERE FOUND TO HAVE BEEN USED BY PATIENTS. HOWEVER, NO COMPLAINTS WERE RECEIVED BY CORENTEC IN USING THIS PRODUCT. THE TOTAL QUANTITY MANUFACTURED FOR LOT: 2BBBMLE9 FOUND IS 2EA, AND ALL 2EA QUANTITIES HAVE BEEN TRACKED. NO COMPLAINTS HAVE YET BEEN MADE TO CORENTEC REGARDING 2EA'S PRODUCTS THAT HAVE ALREADY BEEN USED ON PATIENTS, BUT CORENTEC WILL ACCEPT MDRS TO REPORT THIS ISSUE AS A PREEMPTIVE RESPONSE AND TRY TO FIND ESSENTIAL INFORMATION ABOUT MDRS. TO ADDRESS THIS ISSUE, CORRECTIVE ACTIONS WILL BE ISSUED SO THAT ROOT CAUSE ANALYSIS CAN BE FOUND.

    Description of Event or Problem · 0

    THE ISSUE WAS THAT THE 28M LABEL WAS ATTACHED TO THE METAL HARD SIZE 28S SHIPPED TO THE DEALERSHIP. AS A RESULT OF CONFIRMATION, BOTH PRODUCTS WERE CONFIRMED TO HAVE BEEN IMPLANTED INTO THE PATIENT'S BODY. BUT THERE WERE NO SEPARATE CUSTOMER COMPLAINTS FROM PATIENTS OR SPECIALISTS, AND CORENTEC DISCOVERED THIS PROBLEM FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228585 BENCOX TOTAL HIP SYSTEM METAL HEAD LPH CORENTEC CO.,LTD. 01.02.405 2BBBMLE9 08806373830600

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other