BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MODULAR KNEE, PRESS FIT 38 OVAL PATELLA

    MDR report key: 152843 · Received February 27, 1998

    Report

    Report Number
    1219655-1998-00026
    Event Type
    Injury
    Date Received
    February 27, 1998
    Date of Event
    August 6, 1994
    Report Date
    February 27, 1998
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ALL RELEVENT MFG DOCUMENTATION RELATING TO THE PFC PATELLA, 86-4172, LOT 01W7 HAS BEEN REVIEWED AND NO DISCREPANCIES WERE FOUND. AT THIS TIME, JJPI CONSIDERS THIS FILE CLOSED. NON-DESTRUCTIVE VISUAL EXAMINATION WAS PERFORMED ON THE DEVICE. THE POROUS COATED PATELLA WAS REVISED DUE TO DISASSOCIATION OF THE POLYETHYLENE DOME FROM THE POROUS MEATAL. BACKING. THE ARTICULATING SURFACE OF THE PATELLA SHOWED SOME BURNISHING WEAR AND DEFORMATION WHILE THE WEAR ON THE TIBIAL INSERT WAS LIMITED. OTHER THAN THE WEAR ON BOTH THE FEMORAL COMPONENT AND THE METAL BACKING OF THE PATELLA COMPONENT DUE TO THEIR ARTICULATION FOLLOWING DISASSASSOCIATION OF THE POLYETHYLENE DOME, THERE WERE NO UNEXPECTED FEATURES NOTED ON ANY OF THE OTHER COMPONENTS. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS WERE NOTED IN ANY OF THE COMPONENTS. AT THIS TIME, JJPI CONSIDERS THIS FILE TO BE CLOSED.

    Description of Event or Problem · 1

    PER PT'S ATTORNEY, THE DEVICE IS ALLEGEDLY DEFECTIVE. NO DETAILS HAVE BEEN GIVEN TO SUPPORT THIS CLAIM. THE PT DID UNDERGO REVISION SURGERY ON 8/6/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC MODULAR KNEE, PRESS FIT 38 OVAL PATELLA Implant KNEE PROSTHESIS, PRESS FIT OVAL PATELLA HTG JOHNSON & JOHNSON PROFESSIONALS, INC. NA 01W7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PFC FEMORAL COMPONENT, CAT# 86-4102, LOT # 5K67| PFC TIBIAL INSERT, CAT# 86-4609, LOT # 5E98,| PFC TIBIAL TRAY, CAT# 86-6023, LOT # 2J05