BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR FLEX ARTICULAR SURFACE

    MDR report key: 2230789 · Received August 23, 2011

    Report

    Report Number
    1822565-2011-01904
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    September 14, 2009
    Report Date
    July 27, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 DRAINAGE AND DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60112676

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention NEXGEN CR FLEX FEMORAL COMPONENT:| (B)(4)| LOT #60129819 (B)(4)| CATALOG #00598004702, LOT #60121432| (B)(4)| NEXGEN ALL POLY PATELLA: CATALOG #00597206532| CATALOG #00597001602, LOT #60111486| NEXGEN STEMMED TIBIAL COMPONENT: