BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3982415 · Received August 6, 2014

    Report

    Report Number
    3005477969-2014-00446
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    January 6, 2015
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO GROIN PAIN. A SMALL AMOUNT OF METALLOSIS WAS EVIDENT AT THE POLAR ASPECT OF THE ACETABULUM. IMPLANTATION WAS IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460823 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08CW16036 009

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R FEMORAL HEAD, # 74123144, LOT # ---W14919 052| FEMORAL HEAD, PART #74123144 AND LOT #NI