BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA POSTERIOR LIPPED INSERT

    MDR report key: 172927 · Received June 18, 1998

    Report

    Report Number
    1219655-1998-00111
    Event Type
    Injury
    Date Received
    June 18, 1998
    Date of Event
    May 15, 1998
    Report Date
    June 18, 1998
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON CAT#96-0242, PFC SIGMA TIBIAL INSERT. THE INSERT WAS REMOVED DUE TO PAIN, SWELLING, OSTEOLYSIS, AND POSSIBLE INFECTION. THE INSERT DEMONSTRATED AREAS OF YELLOW DISCOLORATION, BURNISHING, PITTING, AND SCRATCHING COVERING APPROX 35 % OR EACH CONDYLE. THERE WERE ALSO AREAS OF YELLOW DISCOLORATION ON THE INFERIOR SIDE OF THE INSERT, SIMILAR TO SIZE AND LOCATION TO THE DISCOLORED AREAS ON THE SUPERIOR SIDE. NO APPARENT MATERIAL OR MFG DEFECTS WERE NOTED ON THE COMPONENT. AT THIS TIME, JJPI CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    REVISION SURGERY FOUND PITTING AND DISCOLORATION OF THE CONDYLES OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA POSTERIOR LIPPED INSERT Implant PROSTHETIC KNEE - POSTERIOR LIPPED INSERT JWH JOHNSON & JOHNSON PROFESSIONAL, INC. NA 02756A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention