BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2940431 · Received February 4, 2013

    Report

    Report Number
    3005477969-2013-00035
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 24, 2013
    Report Date
    April 12, 2013
    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 PAIN AND ELEVATED METAL ION LEVELS. THE PATIENT CONSULTED HER SURGEON IN LATE 2012 COMPLAINING OF PAIN FOLLOWING HER DAILY EXERCISE ROUTINE, WITH THE PAIN BEING EXACERBATED FOLLOWING A 20KM HIKE. X-RAYS WERE TAKEN AND DID NOT REVEAL ANYTHING SUSPICIOUS. BLOOD TESTS SHOWED ELEVATED METAL ION LEVELS. THE IMPLANTS WERE REPORTEDLY WELL FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46914 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 62680 012

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R FEMORAL HEAD, PART # 74121146, LOT # 66635 026| FEMORAL HEAD, PART# 74121146, LOT# 66635