BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2140291 · Received June 27, 2011

    Report

    Report Number
    3005477969-2011-00124
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    March 25, 2011
    Report Date
    February 14, 2012
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY HAS BEEN PERFORMED DUE TO METALLOSIS AND A SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 51138 018

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R FEMORAL HEAD, PART#74124046, LOT UNKNOWN| FEMORAL HEAD, PART#74222150, LOT NUMBER UNKNOWN