BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2873413 · Received December 14, 2012

    Report

    Report Number
    3005477969-2012-00426
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    December 13, 2012
    Report Date
    March 21, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE CORRECTED. NO DEVICES WERE RETURNED FOR ANALYSIS, HOWEVER X-RAYS SHOWING DEVICE ORIENTATION WERE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO GROIN AND THIGH PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DOES NOT FAULT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 09FW23640

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R FEMORAL HEAD, PART# 74123144, LOT# 08JW18919