BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN DISTAL FEMORAL AUGMENT BLOCK

    MDR report key: 2060969 · Received March 14, 2011

    Report

    Report Number
    1822565-2011-00574
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    September 9, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THIS PRODUCT IS PACKAGED IN A POLYETHYLENE BAG TO HELP IMMOBILIZE AND PROTECT THE PRODUCT. THE POLY BAG IS NOT SEALED AND DOES NOT FUNCTION AS A STERILE BARRIER. THE STERILE BARRIER (INNER TRAY) DID NOT APPEAR TO HAVE ANY DEFECTS THAT WOULD HAVE RESULTED IN A COMPROMISED STERILE BARRIER. THERE IS NO EVIDENCE OF MELTING OF THE POLY BAG AS MENTIONED. HOWEVER, THE POLY BAG DOES EXHIBIT SOME TEARING AND SCUFF MARKS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION 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 STERILE PLASTIC PACKAGING INSIDE THE STERILE CONTAINER IS NOT SEALED BUT APPEARS TO BE MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN DISTAL FEMORAL AUGMENT BLOCK JWH ZIMMER, INC. 79156900

    Patients

    Seq Age Sex Outcome Treatment
    1