BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2232171 · Received September 2, 2011

    Report

    Report Number
    3005477969-2011-00210
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 23, 2011
    Report Date
    March 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 33299 140

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R FEMORAL HEAD, PART# 121446, LOT #35040| FEMORAL STEM, # 71309011, LOT # 04LM05023A| FEMORAL HEAD, PART#121146, LOT #35040