BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2031152 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00706
    Event Type
    Injury
    Date Received
    March 22, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD HEMATOMA REMOVED FROM KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 60502635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN ALL POLY PATELLA, CATALOG# 00597206541,| CATALOG # 00598004701, LOT# 61071679| CATALOG # 00595204010, LOT# 61069316| MFG AT ZIMMER B.V., (B)(4)| NEXGEN STEMMED TIBIAL COMPONENT,| LOT# 61087926,MFG AT (B)(4)| NEXGEN PROLONG CR ARTICULAR SURFACE,