BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC TOTAL CONDULAR 3 REINFORCED TIBIAL INSERT

    MDR report key: 128884 · Received October 30, 1997

    Report

    Report Number
    1219655-1997-00168
    Event Type
    Injury
    Date Received
    October 30, 1997
    Date of Event
    August 13, 1997
    Report Date
    October 30, 1997
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE JJPI APPLIED RESEARCH GROUP EVALUATIONS ARE AS FOLLOWS. NON-DESTRUCTIVE AND VISUAL EVALUAITON WAS PERFORMED ON THE 80-0163 PFC TIBIAL INSERT. THE ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE INSERT WAS REVISED AFTER APPROXIMATELY TWO YEARS DUE TO FAILURE OF THE INTERCONDYLAR POST. THE INTERCONDYLAR POST SHOWED CRACKING AND DELAMINATION ON THE MEDIAL, LATERAL AND POSTERIOR SIDES. THE ARTICULATING SURFACES OF THE CONDYLES SHOWED EXTENSIVE BURNISHING AND SOME PITTING AND SCRATCHING. THE INFERIOR SIDE OF THE INSERT SHOWED SLIGHT MANUFACTURING DEFECTS WERE EVIDENT. JJPI CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED INSTABILITY, CRACKING NOISE AND JOINT SWELLING. REVISION SURGERY WAS PERFORMED ON 8/13/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC TOTAL CONDULAR 3 REINFORCED TIBIAL INSERT Implant PROSTHETIC KNEE-TIBIAL INSERT HSH JOHNSON & JOHNSON PROFESSIONALS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention