BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3791708 · Received May 6, 2014

    Report

    Report Number
    3005477969-2014-00297
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    June 19, 2013
    Report Date
    June 13, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FUNCTIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272391 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 85069 010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R FEMORAL HEAD, PART AND LOT# UNKNOWN| FEMORAL HEAD, # 74121146, LOT # 63409 059