BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2820033 · Received November 6, 2012

    Report

    Report Number
    3005477969-2012-00348
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 30, 2012
    Report Date
    February 14, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMBINATION OF DEVICES USED IN THIS CASE CONSTITUTE AN OFF LABEL APPLICATION IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS AND PAIN. IMPLANTATION WAS IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 82004 002

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R FEMORAL HEAD, PART AND LOT # UNKNOWN| MODULAR SLEEVE, PART# 74222100, LOT# 07LW14957| HEMI HEAD, PART# 74122554, LOT# 07LW14622 021