BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3882674 · Received June 19, 2014

    Report

    Report Number
    3005477969-2014-00370
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 17, 2014
    Report Date
    January 13, 2015
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE SURGEON NOTED THAT THE ACETABULAR CUP WAS IN AN OPEN POSITION ON X-RAYS TAKEN PRIOR TO REVISION. METALLOSIS REPORTEDLY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361543 BHR ACETABULAR CUP NXT SMITH & NEPHEW 31641 020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R MODULAR HEAD, # 121442, LOT # 31181| FEMORAL STEM, # 71309012, LOT # 04DM11543A