BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SULZER MEDICA - HINGE KIT

    MDR report key: 402595 · Received June 19, 2002

    Report

    Report Number
    402595
    Event Type
    Malfunction
    Date Received
    June 19, 2002
    Date of Event
    December 3, 2001
    Report Date
    June 7, 2002
    Manufacturer
    SULZER MEDICA
    Product Code
    HRZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIC HARDWARE WAS DEFECTIVE AND PT WAS REQUIRED TO RETURN TO THE OR. MEDICAL RECORD INDICATES A SECONDARY DIAGNOSIS OF "MECHANICAL COMPLICATION OF INTERNAL ORTHOPEDIC DEVICE/IMPLANT/GRAFT." SURGICAL OPERATIVE, IMPLANT ARTIFICIAL INTERNAL DEVICE, WITH ABNORMAL RESECTION LATER COMPLICATION, NO SURGICAL MISADVENTURE. TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULZER MEDICA - HINGE KIT ORTHOPEDIC - KNEE PROSTHESIS HRZ SULZER MEDICA MOST HINGE KIT 1496198

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other