BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FLEX FEMORAL COMPONENT

    MDR report key: 1990889 · Received February 8, 2011

    Report

    Report Number
    1822565-2011-00189
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAD PAIN RIGHT AFTER SURGERY AND ONLY 85 DEGREES RANGE OF MOTION. SURGEON HAS RECOMMENDED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS FLEX FEMORAL COMPONENT JWH ZIMMER INC 60454696

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other CATALOG #00596009900, LOT #60459993| MANUFACTURED ZIMMER B.V.| NEXGEN COMPLETE KNEE SOLUTION TAPER STEM PLUG,| UNKNOWN POLY PATELLA, CATALOG # UNK, LOT # UNK| COMPONENT, CATALOG #00598004701, LOT #60494540,| NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL