BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET

    MDR report key: 6604476 · Received May 30, 2017

    Report

    Report Number
    MW5070106
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Report Date
    May 30, 2017
    Manufacturer
    ZIMMER BIOMET
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MFR: ZIMMER BIOMET. THE INSTRUMENT IN QUESTION IS THE DISTAL FEMORAL CUTTING BLOCK WITHOUT HANDLE. THIS ISSUE COMES FROM THE CUTTING BLOCK BASES HAVING RECESSED HOLES WITH MAGNETIC INSERTS. OUR BEST EXPLANATION IS THAT BLOOD AND BIO-BURDEN ARE ABLE TO MOVE WITHIN THE SPACE BETWEEN THE HOLES AND THE INSERTS WHERE IT IS NOT ABLE TO BE PROPERLY CLEARED/REMOVED. ONCE THE "VISUALLY CLEAN" BLOCK IS PLACED IN THE AUTOCLAVE AND HEATED THE BLOCK EXPANDS ALLOWING THE PREVIOUSLY UNDETECTED BIO-BURDEN TO PUSHED TO THE SURFACE OF THE MAGNETIC INSERT AND RECESSED BLOCK LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378262 ZIMMER BIOMET FEMORAL CUTTING BLOCK W/O HANDLE LXH ZIMMER BIOMET ZB090511
    378263 ZIMMER BIOMET FEMORAL CUTTING BLOCK W/O HANDLE LXH ZIMMER BIOMET ZB090320
    378264 ZIMMER BIOMET FEMORAL CUTTING BLOCK W/O HANDLE LXH ZIMMER BIOMET 652050

    Patients

    Seq Age Sex Outcome Treatment
    1