BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN DISTAL FEMORAL PRECOAT AUGMENT BLOCK

    MDR report key: 6001250 · Received October 5, 2016

    Report

    Report Number
    0001822565-2016-03571
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    August 30, 2016
    Report Date
    April 28, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK946150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. DEVICE RECEIVED BUT NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT THE TYVEK LID OF THE OUTER CAVITY IS MISSING. INSIDE THE BOX WERE THE TWO TYVEK CAVITIES AND PRODUCT LABELS. ONE LABEL HAS "2/2010" HANDWRITTEN ON IT. INSPECTION OF THE OUTER THERMOFORMED CAVITY FOUND THAT THE EDGE OF THE OUTER CAVITY IS STILL COMPLETELY COVERED WITH DRIED GLUE. THE PACKAGE EVALUATION CONCLUDED THAT THE BOX WAS NOT PROPERLY OPENED AS THE SEAL STICKER SPREAD ACROSS THE TOP AND SIDE OF CONTAINER WAS STILL INTACT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE HISTORY RECORDS FOR THE 00-5990-037-20, LOT # 60987042 WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. A STOCK INQUIRY FOUND THAT NO PRODUCT FROM THAT LOT IS AVAILABLE IN INVENTORY. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR MISSING TYVEK LID FOR PART #00599003720 OR LOT #60987042. THE PRODUCT WAS MANUFACTURED AND PACKAGED IN 2008, AND HAS BEEN IN TRANSIT AN UNKNOWN NUMBER OF TIMES OVER THE 8 YEARS PRIOR TO THE REPORTED EVENT. THE PRESENCE OF THE DRIED GLUE COMPLETELY COVERING THE EDGE OF THE OUTER CAVITY INDICATES THAT THE DEVICE WAS PROPERLY SEALED AT THE TIME OF MANUFACTURING. THE HANDWRITTEN DATE NOTICED ON THE STICKERS WAS ALMOST TWO YEARS AFTER THE MANUFACTURING OF THE DEVICE. THIS DATE AND THE FACT THAT THE PACKAGE'S OUTER SEAL WAS NOT OPENED PROPERLY SEEM TO INDICATE THAT THE PACKAGE HAD PREVIOUSLY BEEN OPENED AND RE-WRAPPED. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANT PACKAGING WAS FOUND INCOMPLETE WITH A MISSING TYVEK LID, AND THERE WAS WRITING ON ONE OF THE LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652427 NEXGEN DISTAL FEMORAL PRECOAT AUGMENT BLOCK KNEE PROSTHESIS JWH ZIMMER, INC. 60987042

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR