BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL TOTAL WRIST SYSTEM

    MDR report key: 1074913 · Received July 9, 2008

    Report

    Report Number
    3004608878-2008-00047
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 9, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    KWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE COMPONENTS INVOLVED IN THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PATIENT WHO RECEIVED A UNIVERSAL TOTAL WRIST SYSTEM FOR SLAC (SCAPHOLUNATE ADVANCED COLLAPSE) HAD TO UNDERGO REVISION SURGERY BECAUSE OF SEPTIC LOOSENING. THE REVISION PROCEDURE SHOWED A LOOSENING OF TWO SCREWS OF THE CARPAL COMPONENT AND ONE SCREW OF THE RADIAL COMPONENT. INFLAMMATION OF THE BONE WAS SEEN PREDOMINATELY ALONG THE TWO SCREWS OF THE CARPAL COMPONENT, BUT ALSO IN OTHER AREAS OF THE WRIST. AN INTERIM CEMENT SPACER WAS PLACED IN THE WRIST AFTER THE EXPLANTATION PROCEDURE. INFORMATION RECEIVED IN WRITING BY INTEGRA INDICATES THAT THE PATIENT HAD NO OTHER PRE-EXISTING MEDICAL CONDITIONS, AND THAT MICROBIOLOGY FINDINGS FROM THE EXPLANTED DEVICES ARE NOT AVAILABLE. THE THREE UNIVERSAL TOTAL WRIST SYSTEM COMPONENTS REPORTED IN THIS EVENT ARE: RADIAL IMPLANT LARGE RIGHT (CATALOGUE NUMBER: 263400R LOT NUMBER: 7672). CARPAL IMPLANT LARGE (CATALOGUE NUMBER: 261401, LOT NUMBER: 9016). CARPAL POLY IMPLANT LARGE (CATALOGUE NUMBER: 262400, LOT NUMBER: 785).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TOTAL WRIST SYSTEM PROSTHESIS, WRIST 3 PART METAL PLASTIC KWM INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention