BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION FLUTED STEM MOBILE TIBIAL COMPONENT OPTION

    MDR report key: 1082793 · Received July 24, 2008

    Report

    Report Number
    1822565-2008-00443
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE OUTER CARTON APPEARS TO HAVE BEEN PUNCTURED ALONG THE BOTTOM OF THE PACKAGING MATERIAL. THE SHRINK WRAP MATERIAL HAS NOT BEEN PUNCTURED COMPLETELY THROUGH BUT SHOWS EVIDENCE OF ABRASION. IT IS LIKELY, THAT THE DEVICE EXPERIENCED SOME TYPE OF EXTREME TRANSIT DAMAGE AFTER DISTRIBUTION THAT CAUSED THE HOLE IN THE CARTON. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. THE MANUFACTURED LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THIS KIND.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE PROCESSING RECEIPT OF NEW CONSIGNMENT, I NOTICED A HOLE IN THE BOTTOM OF THE BOX. HOSPITAL WILL NOT ACCEPT AS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION FLUTED STEM MOBILE TIBIAL COMPONENT OPTION KNEE PROSTHESIS NJL ZIMMER, INC. NA 60872897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK