BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN ROTATING HINGED KNEE

    MDR report key: 272400 · Received April 6, 2000

    Report

    Report Number
    MW1018588
    Event Type
    Injury
    Date Received
    April 6, 2000
    Date of Event
    March 10, 2000
    Report Date
    March 21, 2000
    Manufacturer
    BIOMET INC
    Product Code
    HRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT'S LEFT TIBIA HAD AN IMPENDING PATHOLOGIC FRACTURE. IN 1998 THE PT UNDERWENT A RADICAL RESECTION OF PROXIMAL TIBIA AND A PROSTHETIC RECONSTRUCTION ROTATING HINGE KNEE, MEDIAL GASTROCNEMIUS FLAP AND SPLIT THICKNESS SKIN GRAFT. THE PT PRESENTED ON 03/17/2000 WITH COMPLAINT OF SUDDEN ONSET OF INSTABILITY WHEN AMBULATING ON THE LIMB. ON RADIOGRAPHIC EXAM AND CLINICAL EXAM IT WAS DETERMINED THAT THERE WAS A FRACTURE OF THE YOKE OF PT'S ROTATING HINGE ORTHOSIS. IN 2000 THE PT HAD A REVISION OF THE LEFT ROTATING HINGE KNEE, REPLACING THE YOKE, AXLE AND TIBIAL BEARINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINN ROTATING HINGED KNEE STANDARD REINFORCED ALLOY HRZ BIOMET INC ALLOY 153865 579160
    2 FINN ROTATING HINGED KNEE TIBIAL BUSHING HRZ BIOMET INC TIBIAL BUSHING 153851 569520

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention