BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY MFG TOTAL KNEE REPLACEMENT

    MDR report key: 401981 · Received June 24, 2002

    Report

    Report Number
    MW1025410
    Event Type
    Injury
    Date Received
    June 24, 2002
    Date of Event
    February 13, 2002
    Report Date
    June 24, 2002
    Manufacturer
    DEPUY INDIANA
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT PART IS WEARING OUT IN LESS THAN THREE YEARS. STARTED HAVING PROBLEMS IN 2001.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/10/02: THE CATALOG NUMBER (PRODUCT CODE) OF THE DEVICE IS LISTED IN THE MEDICAL DEVICE REPORT IS 960340. THIS PRODUCT IS DESCRIBED AS PFC SIGMA CURVED INSERT SIZE 2.5 8MM, AND IT IS A POLYETHYLENE BEARING INSERT USED IN TOTAL KNEE REPLACEMENT. THE LOT NUMBER OF THE DEVICE IS 43093A. DEPUY SUBMITTED AN MDR FOR THIS EVENT ON 6/14/02. THE MDR NUMBER ASSIGNED TO THIS REPORT IS 1818910-2002-00310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY MFG TOTAL KNEE REPLACEMENT TOTAL KNEE REPLACEMENT JWH DEPUY INDIANA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| S