BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL SMALL RIGHT

    MDR report key: 3848339 · Received May 19, 2014

    Report

    Report Number
    3004608878-2014-00058
    Event Type
    Injury
    Date Received
    May 19, 2014
    Report Date
    April 28, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED 'A SURGEON FORM THE (B)(6) CONTACTED A SURGEON IN THE US 'REGARDING A PATIENT OF HIS THAT NEEDS A REVISION OF HER TOTAL WRIST REPLACEMENT". SEE MFG REPORT NUMBER 3004608878-2014-00031. ON (B)(6) 2014, ADDITIONAL INFORMATION WAS RECEIVED BY INTEGRA RELATED TO MFG REPORT NUMBER 3004608878-2014-00031. THERE WERE TWO ADDITIONAL DEVICES IMPLANTED AT THE INITIAL SURGERY. THIS REPORT CONCERNS PRODUCT ID 263200R. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2006. THE PATIENT DEVELOPED PAIN AND DISCOMFORT IN HER WRIST; TOWARDS THE END OF 2013 (A PRECISE DATE WAS NOT PROVIDED). SHE WAS DIAGNOSED WITH LOOSENING OF THE PROSTHESIS. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295850 RADIAL SMALL RIGHT NA JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA 9094-32R-9522

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention