BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCOX HIP SYSTEM

    MDR report key: 10806682 · Received November 8, 2020

    Report

    Report Number
    3009106092-2019-00001
    Event Type
    Injury
    Date Received
    November 8, 2020
    Date of Event
    November 4, 2019
    Report Date
    October 25, 2019
    Manufacturer
    CORENTEC CO.,LTD.
    Product Code
    LPH
    UDI-DI
    0880637380709
    PMA / PMN Number
    K122099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENTS WAS CONFORMED BY OPERATIVE NOTES PROVIDED, AND IT STATES THAT "DEVELOPED HIGH LEVEL OF COBALT METAL ION POISONING THAT REQUIRED THE HIP TO BE EXPLANTED AND REPLACED IN 2019".CORENTEC DID THE INVESTIGATION BY LITERATURE, PAPER RESEARCH, CASE STUDY, AND OCCURRENCE LIKELIHOOD STUDY FOR THE REPORTED EVENTS, BUT HAS NOT FOUND ANY TRENDS OR SOMETHING UNUSUAL THAT CAUSE THE COBALT METAL ION POISONING SPECIFICALLY RELATED WITH CORENTEC IMPLANTS STATED IN THE MDR (MW5089740) IN THE METAL ON POLY BEARING. ALSO, THE REVIEW OF DEVICE HISTORY RECORDS IDENTIFIES THAT NO DEVIATION HAS BEEN RECORDED DURING ALL PROCESS SUCH AS MANUFACTURING, MEASUREMENT, STERILIZATION, PACKAGING AND SO FORTH. ALL MATERIALS USED IN THE CONCOMITANT MEDICAL DEVICE IS FULLY EQUIVALENT WITH THE MATERIALS STATED IN EACH 510(K) SUMMARY CLEARED BY THE AGENT. CORENTEC HAS TRIED TWICE FOR RETRIEVAL OF THE IMPLANTS EXPLANTED TO INVESTIGATE THE TREND AND ANALYZE THE ROOT CAUSE, BUT THE IMPLANTS HAVE NOT BEEN RETRIEVED UNTIL THIS REPORTING DATE. THEREFORE, CORENTEC CAN NOT DETERMINED THE ROOT CAUSE OF THE EVENTS FOR NOW. IF ANY FURTHER INFORMATION THAT WOULD RESUME THE ROOT CAUSE ANALYSIS IS FOUND OR REPORTED, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. IN THE MEANWHILE CORENTEC'S WATCH FOR THE TRENDS WILL PERSIST.

    Description of Event or Problem · 1

    EXPERIENCED PROBLEMS AFTER LEFT HIP REPLACEMENT USING CORENTEC SET OF COMPONENTS. DEVELOPED HIGH LEVEL OF COBALT METAL ION POISONING THAT REQUIRED THE HIP TO BE EXPLANTED AND REPLACED IN LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271851 BENCOX HIP SYSTEM FEMORAL BALL HEAD LPH CORENTEC CO.,LTD. 01.02.452 2AAEJ04 0880637380709

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Hospitalization H1.A11.1058 (BENCOX MIRABO CUP 58MM),| H1.L61.3648 (BENCOX MIRABO PE LINER 36/48)| HA.F22.1007 (BENCOX M STEM #7)