BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2941162 · Received February 4, 2013

    Report

    Report Number
    3005477969-2013-00041
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    October 25, 2012
    Report Date
    April 12, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, PERI-PROSTHETIC FRACTURE, AND SOFT TISSUE REACTION. THE PATIENT REPORTEDLY HAD PAIN IN LEFT SIDE HIP SINCE 2009. IN (B)(6) 2012, THE PATIENT FELL AND BANGED THE HIP AND AFTERWARD WAS MORE ACUTELY IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47145 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 22420 033

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ACETABULAR CUP, PART# 74121142, LOT# UNKNOWN| FEMORAL HEAD, PART # 74121142, LOT # 26017 070