BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) PROLONG HIGHLY CROSSLINKED

    MDR report key: 1220794 · Received October 31, 2008

    Report

    Report Number
    1822565-2008-00753
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FOREIGN MATERIAL WAS NOT RETURNED FOR EVALUATION. WITH THE AVAILABLE INFO IT CAN NOT BE DEMONSTRATED WITH CERTAINTY THAT THE SOURCE OF THE HAIR IS THE PACKAGING ENVIRONMENT. THE PACKAGING ENVIRONMENT UTILIZED FOR THIS PRODUCT IS A CLASS 100,000 CLEAN ROOM THAT UNDERGOES CONTINUOUS MONITORING. THERE IS A VERY MINISCULE, BUT CONSTANT RISK OF FOREIGN MATERIAL IN STERILE CAVITIES FROM THE OPERATORS. A REVIEW OF COMPLAINTS FOR HAIR IN STERILE IMPLANTS WAS CONDUCTED IN MARCH 2005 AND INDICATED THAT THERE IS LESS THAN ONE COMPLAINT PER MILLION IN STERILE UNITS SHIPPED BY ZIMMER WARSAW IN THE PAST 5 YEARS. THE RELATED MANUFACTURING LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THE KIND. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCRUB TECH OPENED THE IMPLANT AND FOUND A HAIR ON THE IMPLANT. SCRUB TECH DOES NOT BELIEVE THAT THE HAIR FELL IN THE PACKAGING UPON OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) PROLONG HIGHLY CROSSLINKED KNEE PROSTHESIS JWH ZIMMER, INC. NA 60995297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK