BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS ARTICULAR SURFACE

    MDR report key: 1940904 · Received December 23, 2010

    Report

    Report Number
    1822565-2010-01450
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    August 31, 2009
    Report Date
    November 30, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED PAIN AND UNDERWENT EXPLORATORY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER INC 60403942

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR POSTERIOR STABILIZED (LPS) FEMORAL COMPONENT,| CATALOG #00599601702, LOT #60490053.| COMPONENT, CATALOG #00598005701, LOT #60512311| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE -| NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL