BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3082515 · Received April 29, 2013

    Report

    Report Number
    3005477969-2013-00164
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND A POSSIBLE SOFT TISSUE REACTION. THE ACETABULAR CUP REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183663 BHR HEMI HEAD NXT SMITH & NEPHEW ORTHOPAEDICS LTD 09BW04044

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R MODULAR SLEEVE, # (B)(4), LOT # 08HW18190| ACETABULAR CUP, PART AND LOT # UNKNOWN