BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY-INTRA-ARTICULAR 014

    MDR report key: 1686078 · Received May 11, 2010

    Report

    Report Number
    MW5015924
    Event Type
    Injury
    Date Received
    May 11, 2010
    Date of Event
    January 20, 2010
    Report Date
    May 5, 2010
    Manufacturer
    DEPUY UNI XLK BEARING INSERT
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TIBIAL TRAY INSERT COMPONENT WAS INADVERTENTLY DISCARDED AFTER OPENING. THE PROBLEM IS THAT THE INSET IS WHITE, AND THE PACKAGING IS ALSO PURE WHITE. PACKAGING SHOULD BE ANOTHER COLOR TO PROVIDE VISIBLE CONTEST. (B) (6) HOSPITAL IS A VERY SMALL CRITICAL ACCESS HOSPITAL. THE DEPUY REP HAD NOT BEEN 'ALLOWED' TO BRING MORE THAN ONE 'PART' OF ANY PARTICULAR SIZE FROM (B) (4) UP TO (B) (6). WHEN THE PACKAGE WAS OPENED, IT WAS SET ON THE TABLE FOR USE BY THE MD. SURG TECH GLANCED AND THOUGHT MD HAD PICKED IT UP, AND DISCARDED THE PACKAGING, WITH THE INSERT IN IT. 'PATIENT HAD TO BE RECOVERED AND THEN COME BACK TO THE OPERATING ROOM LATER IN DAY, AFTER A SECOND DEVICE HAD BEEN FLOWN UP FROM (B) (4). (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY-INTRA-ARTICULAR 014 TIBIAL INSERT HSH DEPUY UNI XLK BEARING INSERT L44J51000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization