BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY (JOHNSON & JOHNSON)

    MDR report key: 476887 · Received August 4, 2003

    Report

    Report Number
    476887
    Event Type
    Injury
    Date Received
    August 4, 2003
    Date of Event
    May 6, 2003
    Report Date
    August 1, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/24/03: THE CATALOG NUMBER LISTED IN THE MEDICAL DEVICE REPORT IS 960121. THIS IS A 28MM PFC SIGMA PATELLA COMPONENT. THE MANUFACTURING LOT NUMBER LISTED IN THE MEDICAL DEVICE REPORT IS 161315. DEPUY SUBMITTED AN INITIAL MDR FOR THIS EVENT ON AUGUST 28, 2003. THE MDR NUMBER ASSIGNED TO THIS REPORT IS 1818910-2003-00576.

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP FOR REMOVAL OF PATELLA COMPONENT STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY (1999) SECONDARY TO FRAGMENTATION OF THE PATELLA AND FAILURE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY (JOHNSON & JOHNSON) RIGHT PATELLA COMPONENT OF TOTAL KNEE JWH DEPUY ORTHOPAEDICS UNK 161315

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention