BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC OVAL PATELLA 41MM

    MDR report key: 154081 · Received March 5, 1998

    Report

    Report Number
    1219655-1998-00029
    Event Type
    Injury
    Date Received
    March 5, 1998
    Date of Event
    January 12, 1998
    Report Date
    March 5, 1998
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONAL, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON THE 86-4027 PFC PATELLA AND THE 86-4158 PFC TIBIAL INSERT WHICH WERE REMOVED DURING REVISION SURGERY TO IMPROVE KNEE STABILITY, REDUCE PATELLA DISLOCATION, AND REMOVE FEMORAL ECTOPIC BONE. THE ARTICULATING SURFACE OF THE ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE PATELLA SHOWED AN ABRADED AREA CAUSED BY ARTICULATION WITH THE ECTOPIC BONE ON THE FEMORAL COMPONENT. THE ARTICULATING SURFACES OF BOTH CONDYLES OF THE INSERT SHOWED AREAS OF BURNISHING, SCRATCHING AND MILD PITTING. THE INFERIOR SIDE OF THE INSERT HAD LIGHT BURNISHING UNDER BOTH THE MEDIAL AND LATERAL CONDYLES. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS NOTED ON EITHER COMPONENT. AT THIS TIME, JJPI CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED RECURRENT DISLOCATION OF THE PATELLA COMPONENT, ECTOPIC BONE FORMATION AND INSTABILITY OF THE PROSTHESIS, AND POLYWEAR OF THE TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC OVAL PATELLA 41MM Implant KNEE PROSTHESIS, OVAL PATELLA HTG JOHNSON & JOHNSON PROFESSIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention LOT# 032038| PFC TIBIAL INSERT 83/55CV 10.0, CAT#86-4158