BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARP POLY, EX-SMALL-STD

    MDR report key: 2489409 · Received March 8, 2012

    Report

    Report Number
    3004608878-2012-00052
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    February 9, 2012
    Report Date
    March 8, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    JWJ
    PMA / PMN Number
    K030037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS ALSO REPORTED IN MFR REPORT NUMBER 3004608878-2012-00048. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE WAS REMOVED DURING REVISION SURGERY. IT WAS IMPLANTED ABOUT FIVE YEARS AGO. THE IMPLANT SHOWED CORROSION OF THE SCREW HOLE ON THE ULNAR SIDE OF THE DEVICE. ON INITIAL EXPOSURE, THE SURGEON NOTICED BLACK DEBRIS IN THE WOUND. A SECOND SURGICAL OPINION WAS THAT IT WAS METAL ON METAL CORROSION DEBRIS. THE IMPLANTS WERE REMOVED, DEBRIS WAS REMOVED, AND THE WOUND WAS IRRIGATED BEFORE CLOSURE. NO REPLACEMENT IMPLANT WAS USED. THE PRECISE PRODUCT CATALOGUE NUMBER WAS NOT PROVIDED. INTEGRA HAS REQUESTED ADD'L CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARP POLY, EX-SMALL-STD UNI2 TOTAL WRIST IMPLANT SYSTEM JWJ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention