BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN MAR +4 NEUT 56ODX28ID

    MDR report key: 372165 · Received January 16, 2002

    Report

    Report Number
    1818910-2002-00023
    Event Type
    Malfunction
    Date Received
    January 16, 2002
    Date of Event
    December 18, 2001
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TWO END LABELS (ONE A BARCODE AND THE OTHER A TEXT LABEL) DO NOT MATCH. ONE LABEL READS 1219-28-456; LOT VN4A71022 (BARCODE LABEL). THE ACTUAL PRODUCT IS A 1220-32-152; LOT NUMBER VN9F11022 (WHICH IS ON THE TEXT LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 NEUT 56ODX28ID TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA VN4A71022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other