BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2852131 · Received November 30, 2012

    Report

    Report Number
    3005477969-2012-00406
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 30, 2012
    Report Date
    February 11, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 50981 076

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R FEMORAL HEAD, PART # 74121146, LOT # 54063 072| FEMORAL HEAD, PART AND LOT# UNKNOWN