BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX+ DURATION PATELLA MED

    MDR report key: 199582 · Received November 25, 1998

    Report

    Report Number
    2219689-1998-00661
    Event Type
    Malfunction
    Date Received
    November 25, 1998
    Report Date
    October 24, 1998
    Manufacturer
    HOWMEDICA INC
    Product Code
    HTG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOSPITAL BEGAN TO OPEN IMPLANTS AND DISCOVERED A CUT IN THE WRAP AND IN THE PLASTIC OUTER SHELL. THEY USED BACK-UP IMPLANT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURATION PATELLA MED Implant IMPLANT HTG HOWMEDICA INC NA VFBOA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other