BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN HIP RESURFACING DEVICE

    MDR report key: 5541464 · Received March 30, 2016

    Report

    Report Number
    MW5061405
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    November 1, 2015
    Report Date
    March 17, 2016
    Manufacturer
    CORIN GROUP PLC
    Product Code
    KXA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    SUBACUTE ONSET OF HIP PAIN. LOOSENING OF ACETABULAR COMPONENT, LEFT HIP RESURFACING. ACETABULAR COMPONENT SEPARATED FROM SUBSTRATE (IN-GROWTH SURFACE). THE SURFACE REPLACEMENT FROM CORIN WAS IMPLANTED IN THE UNITED STATES. IT IS NOT FDA APPROVED HERE. AT 12 YEARS AFTER SURGERY THE CUP SEPARATED FROM THE SUBSTRATE USED FOR BONE ATTACHMENT. THE CUP TURNED UPSIDE DOWN GENERATING METALLOSIS AND IMMOBILITY FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191157 CORIN HIP RESURFACING DEVICE HIP RESURFACING KXA CORIN GROUP PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O