BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD III TIBIAL COMPONENT

    MDR report key: 101276 · Received June 25, 1997

    Report

    Report Number
    9612439-1997-00001
    Event Type
    Injury
    Date Received
    June 25, 1997
    Date of Event
    October 1, 1992
    Report Date
    May 29, 1997
    Manufacturer
    SMITH & NEPHEW RICHARDS FRANCE, S.A.
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INITIALLY IMPLANTED IN 10/1992 REQUIRED REVISION ON 1/29/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD III TIBIAL COMPONENT Implant UNICOMPARTMENTAL KNEE SYSTEM HSH SMITH & NEPHEW RICHARDS FRANCE, S.A. NA 136000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R