BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORENTEC HIP REPLACEMENT

    MDR report key: 9008489 · Received September 11, 2019

    Report

    Report Number
    MW5089740
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    October 6, 2016
    Report Date
    September 9, 2019
    Manufacturer
    CORENTEC CO., LTD.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXPERIENCED PROBLEMS AFTER A LEFT HIP REPLACEMENT USING A CORENTEC SET OF COMPONENTS. THE SURGERY WAS DONE BY A (B)(6). DEVELOPED HIGH LEVEL OF COBALT METAL ION POISONING THAT REQUIRED THE HIP TO BE EXPLANTED AND REPLACED IN (B)(6) 2019. CORENTEC COMPONENTS USED IN THE EXPLANTED HIP WERE - 36MM MRABO PE LINER (H1.L61.3648), MIRABO CUP (H1.A11.1058), METAL HEAD (01.02.452), M STEM (HA.F22.1007). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794608 CORENTEC HIP REPLACEMENT PROSTHESIS, HIP SEMI - CONSTRAINED METAL / POLYMER, CEMENTED OR UNCEMENTED KWA CORENTEC CO., LTD. 01.02.452 (METAL HEAD) 1AAELJ04
    794609 36MM MIRABO PE LINER PROSTHESIS, HIP SEMI - CONSTRAINED METAL / POLYMER, CEMENTED OR UNCEMENTED KWA CORENTEC CO., LTD. H1.L61.3648
    794610 MIRABO CUP PROSTHESIS, HIP SEMI - CONSTRAINED METAL / POLYMER, CEMENTED OR UNCEMENTED KWA CORENTEC CO., LTD. H1.A11.1058
    794611 M. STEM PROSTHESIS, HIP SEMI - CONSTRAINED METAL / POLYMER, CEMENTED OR UNCEMENTED KWA CORENTEC CO., LTD. HA.F22.1007

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R| S