BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3070027 · Received April 22, 2013

    Report

    Report Number
    3005477969-2013-00151
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    May 5, 2011
    Report Date
    April 22, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171235 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS, LTD.

    Patients

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