BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2233866 · Received September 5, 2011

    Report

    Report Number
    3005477969-2011-00211
    Event Type
    Injury
    Date Received
    September 5, 2011
    Date of Event
    August 30, 2011
    Report Date
    November 10, 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, SUSPECTED SOFT TISSUE REACTION, FEMORAL NECK THINNING OBSERVED ON X-RAY AND ELEVATED COBALT LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 67588

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R FEMORAL HEAD, PART# 74121146, LOT# ....7 (PARTIAL)