BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER UNI KNEE ARTICULAR SURFACE

    MDR report key: 2042297 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00562
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    September 25, 2009
    Report Date
    September 28, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THIS ISSUE HAS BEEN DETERMINED TO BE A "ONE OFF" ISSUE, BASED ON THE FOLLOWING: BOTH THE LOT FROM ITEM IN THE BOX, AND THE LOT FROM THE INCORRECT LABEL WERE PRODUCED ON THE SAME DAY BY THE SAME OPERATORS IN 2004. THIS MEANS THERE IS A POSSIBILITY OF A FULL LOT FOR LOT SWAP. A REVIEW OF THE COMPLAINT HISTORY REVEALS NO OTHER LABELING COMPLAINTS FOR EITHER OF THESE LOTS. THESE ITEMS ARE BOTH FAIRLY HIGH USE ITEMS, AND IT IS EXPECTED THAT AFTER 5 YEARS, SOME OR MOST FROM BOTH LOTS WOULD HAVE BEEN USED, WHICH WOULD HAVE MEANT THAT THERE WOULD BE MORE COMPLAINTS OF MISLABELING THAN JUST THIS LATEST ONE. HOWEVER, THERE ARE NO PARTS AVAILABLE IN STOCK TO VERIFY THIS. PRODUCT SURVEILLANCE WILL TRACK THE COMPLAINTS FOR THESE ITEMS TO DETERMINE IF FURTHER ACTION IS WARRANTED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BAR CODE READS 00-5842-022-09 AND THE LABEL READS 00-5842-025-08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNI KNEE ARTICULAR SURFACE HSX ZIMMER, INC. 60182199

    Patients

    Seq Age Sex Outcome Treatment
    1