BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY INC

    MDR report key: 40578 · Received September 26, 1996

    Report

    Report Number
    40578
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    August 16, 1996
    Report Date
    August 21, 1996
    Manufacturer
    DEPUY
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TOTAL RT KNEE DONE 1994. LAST SEVERAL MONTHS HAD MARKED INCREASE IN PAIN, SWELLING AND RESTRICTION OF MOTION. ON 7/2/96 ARTHROSCOPY SHOWED FRACTURED POLY WITH A LOOSE PIECE OF THE POLY IN THE KNEE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY INC Implant TOTAL KNEE HSH DEPUY NA 884850000, 960430003

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention