BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC C.R. POROUS COATED FEMORAL COMPONENT

    MDR report key: 137328 · Received December 11, 1997

    Report

    Report Number
    1219655-1997-00180
    Event Type
    Injury
    Date Received
    December 11, 1997
    Date of Event
    November 13, 1997
    Report Date
    December 11, 1997
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAW MATERIAL AND MFG BATCH RECORDS FOR CAT# 864109, LOT# 555CU HAVE BEEN REVIEWED AND NO DISCREPANCIES HAVE BEEN FOUND IN THE DEVICE HISTORY RECORD. JJPI CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    THE FEMORAL COMPONENT WAS BROKEN ON THE MED FEMORAL CONDYLE AT THE CHAMFER. REVISION SURGERY WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC C.R. POROUS COATED FEMORAL COMPONENT Implant PROSTHETIC KNEE-CRUTIATE RETAINING FEMORAL COMPONENT HSA JOHNSON AND JOHNSON PROFESSIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention