BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTIMA CALCAR PLANER

    MDR report key: 173360 · Received June 18, 1998

    Report

    Report Number
    1219655-1998-00116
    Event Type
    Other
    Date Received
    June 18, 1998
    Report Date
    June 18, 1998
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Product Code
    HTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING BATCH RECORD REVIEW WAS CONDUCTED ON PART NUMBER 87-4210, LOT# 369583. ALL RECORDS WERE FOUND TO BE IN ORDER WITH NO MATERIAL OR MANUFACTURING DISCREPANCIES FOUND. A REVIEW OF THE COMPLAINT HISTORY HAS FOUND THIS TO BE AN ISOLATED INCIDENT. AT THIS TIME, JJPI CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    A NON-STANDARD PEN MARKING OF UNK ORIGIN WAS FOUND ON THE DEVICE TRUNION PRIOR TO IMPLANTATION. THE DEVICE WAS IMPLANTED WITHOUT INCIDENT. NO PT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA CALCAR PLANER PROSTHETIC HIP-CALCAR PLANER HTZ JOHNSON & JOHNSON PROFESSIONALS, INC. NA 369583

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN