BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET UK LTD

    MDR report key: 2592442 · Received May 18, 2012

    Report

    Report Number
    MW5025523
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    April 3, 2012
    Report Date
    May 18, 2012
    Manufacturer
    BIOMET UK LTD
    Product Code
    NRA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A PLANNED LEFT UNICOMPARTAMENTAL KNEE ARTHROPLASTY - UKA - PROCEDURE, THE IMPLANT REP VERIFIED WITH THE SURGEON THAT THE TIBIAL BASE PLATE IMPLANT WAS THE CORRECT IMPLANT FOR THE "LEFT" SIDE. THE REP CALLED OUT THE SIZE AND SIDE WHICH THE SURGEON AGREED TO, BUT DID NOT VISUALLY VERIFY WITH THE REP. THE REP LEFT THE OPERATING ROOM AND THEN NOTIFIED THE SURGEON THAT THE IMPLANT WAS FOR A "RIGHT" AND NOT A "LEFT." BY THIS TIME, THE SURGEON WAS CLOSING THE SKIN. A RADIOGRAPH WAS PERFORMED ON THE KNEE AND BASED ON THE IMAGE, THE SURGEON DECIDED TO LEAVE THE IMPLANT IN PLACE AND TO COMPLETE THE CASE. A ROOT CAUSE ANALYSIS WAS PERFORMED AND IT WAS DETERMINED THAT THE LETTERING ON THE PACKAGING OF THE PRODUCT IS SMALL. THE SURGEON CANNOT READ THE PACKAGING WITH THE HOOD (PERSONAL PROTECTIVE EQUIPMENT) ON. A REVIEW OF OTHER PRODUCTS MADE FROM A DIFFERENT MFR SHOW THAT LATERALITY IS CLEARLY MARKED ON THE PACKAGING AND EASY TO SEE FROM A DISTANCE OF SIX TO EIGHT FEET, EVEN THROUGH PPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET UK LTD OXFORD PARTIAL KNEE SYSTEM TRAY SZ D RM RIGHT MEDICAL TIBIAL TRAY NRA BIOMET UK LTD 154725 2585659

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR