BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 4222656 · Received November 4, 2014

    Report

    Report Number
    3005477969-2014-00552
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    February 2, 2015
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE CUP. PATIENT PRESENTED WITH GROIN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705805 BHR ACETABULAR CUP NXT SMITH & NEPHEW 14AW16230

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R FEMORAL HEAD, # 74123148, LOT # NI