BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA DURATION A/P TIB LG 11

    MDR report key: 185060 · Received August 28, 1998

    Report

    Report Number
    2219689-1998-00524
    Event Type
    Malfunction
    Date Received
    August 28, 1998
    Date of Event
    August 11, 1998
    Report Date
    August 27, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT FOLLOWING HOWMEDICA'S RECOMMENDED TECHNIQUE, THE INSERT WAS PUSHED IN PLACE. THERE WAS A "SPRING" MOTION ON THE ANTERIOR ASPECT OF THE INSERT. THE INSERT WAS TAKEN OUT BY PRYING ITS LOCKING LIP UP WITH AN ELEVATOR. AFTER THE SURGEON NOTICED SOME SOFT TISSUE HAD BEEN CAUGHT BETWEEN THE INSERT AND TIBIAL BASEPLATE ON THE LATERO-POSTERIOR SIDE. THE SAME INSERT WAS AGAIN PUSHED IN PLACE AFTER HAVING TAKEN OUT THE SOFT TISSUE AND CLEANING BOTH THE BASEPLATE AND THE INSERT. THERE WAS ONCE AGAIN THE SAME "SPRING" MOTION ON THE ANTERIOR ASPECT OF THE INSERT. ANOTHER INSERT WAS AVAILABLE AND WAS USED SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA DURATION A/P TIB LG 11 Implant IMPLANT HSH HOWMEDICA INC. NA VFVTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other