BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL SIMPLEX P

    MDR report key: 107610 · Received July 2, 1997

    Report

    Report Number
    107610
    Event Type
    Injury
    Date Received
    July 2, 1997
    Date of Event
    April 10, 1997
    Report Date
    May 22, 1997
    Manufacturer
    HOWMEDICA PFIZER HOSP PRODUCTS GROUP
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ORIGINAL LEFT TOTAL KNEE REPLACEMENT WAS DONE 12/22/1994. DEVELOPED LEFT KNEE PAIN AND SWELLING ABOUT 2/1997. ON 4/10/1997 UNDERWENT REPLACEMENT OF THE PATELLA AND THE FEMORAL COMPONENT. OPERATIVE FINDINGS WERE POLYETHYLENE FAILURE OF THE LEFT TOTAL KNEE ARTHROPLASTY, WITH COMPLETE BICOMPARTMENTAL FAILURE OF LEFT KNEE ARTHROPLASTY, COMPLETE POLYETHYLENE WEAR THROUGH OF THE POSTERIOR HALF OF THE MEDIAL AND LATERAL SIDES OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX P Implant RADIOPAQUE BONE CEMENT LOD HOWMEDICA PFIZER HOSP PRODUCTS GROUP * 029325001
    2 AXIOM CENTRAL PEG POLY PATELLA Implant PATELLA JWH HOWMEDICA PFIZER HOSP PRODUCTS GROUP * 026617001
    3 AXIOM KNEE TIBIAL INSERT Implant TIBIAL INSERT HSH HOWMEDICA PFIZER HOSP PRODUCTS GROUP * P9102906

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R