BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3022370 · Received March 27, 2013

    Report

    Report Number
    3005477969-2013-00120
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2012
    Report Date
    March 27, 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. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT SIDED FOOT DROP SINCE PRIMARY SURGERY, ANTALGIC GAIT, IRRITABLE RANGE OF MOVEMENT AND INCREASING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125680 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 53021 048

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R FEMORAL HEAD, PART# 74121142, LOT# 53916 018