BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RT-PLUS

    MDR report key: 3800860 · Received May 8, 2014

    Report

    Report Number
    9613369-2014-00067
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 27, 2014
    Report Date
    August 11, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT MOVEMENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277300 RT-PLUS RT-PLUS MOD FEMORAL COMP. RIGHT 6 CEM JWH SMITH&NEPHEW, INC H1304175

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R 75005525 - RT-PLUS MOD STEM - G1141287| 75005569 - RT-PLUS MOD FEMORAL BLOCK -D1139120