BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3171880 · Received June 17, 2013

    Report

    Report Number
    3005477969-2013-00245
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    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 APPROXIMATELY 18 MONTHS AGO. THE PATIENT CONTINUES TO REPORT PAIN AND COMPLICATIONS POST-REVISION. THE DEVICES WERE REPORTEDLY IMPLANTED 7-8 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273824 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART AND LOT# UNKNOWN