BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 2881661 · Received December 20, 2012

    Report

    Report Number
    3005477969-2012-00434
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 20, 2012
    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. THE PATIENT EXPERIENCED A FALL APPROXIMATELY 1 WEEK PRIOR TO REVISION.

    Devices

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

    Patients

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