BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2190022 · Received August 4, 2011

    Report

    Report Number
    3005477969-2011-00166
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, SOFT TISSUE REACTION, FEMORAL NECK THINNING ON X-RAY, AND REPORTEDLY RAISED COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 079149

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART#74121150, LOT# 079149