BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. MODULAR KNEE SYSTEM TIBIAL INSERT

    MDR report key: 43664 · Received October 22, 1996

    Report

    Report Number
    1219655-1996-00023
    Event Type
    Injury
    Date Received
    October 22, 1996
    Date of Event
    September 27, 1996
    Report Date
    October 21, 1996
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3, H6 - NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON THE 86-4619 PFC PLI TIBIAL INSERT. WEAR WAS OBSERVED ON THE ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE INSERT DURING SURGERY TO INVESTIGATE SOURCE OF KNEE PAIN AND POSSIBLE INFECTION. THE ARTICULATING SURFACES OF BOTH CONDYLES OF THE TIBIAL INSERT SHOWED AREAS OF BURNISHING, DELAMINATION, PITTING, AND AMBER DISCOLORATION. THE INFERIOR SIDE OF THE INSERT HAD LIGHT BURNISHING OVER MOST OF THE SURFACE. IN SUMMARY, DURING SURGERY TO INVESTIGATE THE SOURCE OF ANINFECTION AND COMPLAINTS OF KNEE PAIN, A WORN PFC TIBIAL INSERT WAS OBSERVED AND REPLACED. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS NOTED ON THIS COMPONENT.

    Description of Event or Problem · 1

    PT EXPERIENCED PAIN AND INFECTION IN KNEE. REVISION SURGERY ON 9/27/96 FOUND DELAMINATION OF TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. MODULAR KNEE SYSTEM TIBIAL INSERT Implant POSTERIOR LIPPED TIBIAL INSERT JWH JOHNSON & JOHNSON PROFESSIONAL, INC. NA 76FO

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention