BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FLEX ARTICULAR SURFACE

    MDR report key: 2210654 · Received August 10, 2011

    Report

    Report Number
    1822565-2011-01810
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    February 4, 2008
    Report Date
    July 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED 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 PATIENT UNDERWENT ASPIRATION OF THE RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60027239

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention NEXGEN LPS - FLEX FEMORAL COMPONENT| NEXGEN STEMMED TIBIAL COMPONENT| NEXGEN ALL POLY PATELLA, CATALOG #00597206535| LOT #00366134| NEXGEN TAPER STEM PLUG, CATALOG #00596009900| CATALOG #00596401502, LOT #60212796| (B)(4)| LOT #60212612| (B)(4)| CATALOG #00598004702, LOT #60217889