BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOPAQUE BONE CEMENT

    MDR report key: 203643 · Received December 22, 1998

    Report

    Report Number
    203643
    Event Type
    Injury
    Date Received
    December 22, 1998
    Date of Event
    November 19, 1998
    Report Date
    December 9, 1998
    Manufacturer
    HOWMEDICA PFIZER HOSP PRODUCTS GPS.
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REVISION TOTAL LEFT KNEE - PREVIOUS TOTAL LEFT KNEE DONE 3-6-98 - REMOVED DUE TO BEING LOOSE - REMOVAL OF IMPLANT WAS 11-19-98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOPAQUE BONE CEMENT Implant LEFT KNEE PROSTHESIS LOD HOWMEDICA PFIZER HOSP PRODUCTS GPS. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention