BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM

    MDR report key: 3778186 · Received April 16, 2014

    Report

    Report Number
    3004608878-2014-00041
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    March 27, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REPRESENTATIVE OF A UNIVERSAL2 WRIST CASE WITH SERIOUS OSTEOLYSIS OF THE DISTAL RADIUS. SURGEON HAS NOW DONE THE REVISION OF THE UNIVERSAL2 WRIST. HE USED THE BIOMET FRACTURE MAESTRO SYSTEM FOR THIS PURPOSE. IT WAS CLEAR THAT IT WAS A SUBSTANTIAL WEAR OF THE POLY-COMPONENT (EXACT PRODUCT ID NOT PROVIDED) THAT HAD CAUSED THE BIG OSTEOLYSIS OF THE RADIUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT TO DATE, NO NEW INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233934 UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention