BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXGEN CR FEMORAL COMPONENT

    MDR report key: 51588 · Received November 22, 1996

    Report

    Report Number
    2529767-1996-00009
    Event Type
    Death
    Date Received
    November 22, 1996
    Date of Event
    September 25, 1996
    Report Date
    November 20, 1996
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD AN EPISODE OF LEFT KNEE BUCKLING AND HAS FELT SOMETHING SHIFTING IN HER KNEE SINCE THEN. SHE WAS ADMITTED TO THE HOSP FOR A REVISION. LEFT KNEE-FEMORAL AND TIBIAL COMPONENTS WERE PLACED. ALSO USED AT TIME OF ORIGINAL SURGERY: 5972-65-41, LOT# 65672800, 5972-300-17, LOT # 68447800, 5970-35-02, LOT #68621600.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR FEMORAL COMPONENT Implant CR FEMORAL HSA ZIMMER, INC. NA 66288900

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R