BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 226054 · Received June 2, 1999

    Report

    Report Number
    226054
    Event Type
    Injury
    Date Received
    June 2, 1999
    Date of Event
    April 27, 1999
    Report Date
    April 30, 1999
    Manufacturer
    ZIMMER
    Product Code
    GCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD A LEFT TOTAL KNEE REPLACEMENT IN 1986. SHE DID WELL UNTIL 1990 WHEN SHE FELL AND REQUIRED A REVISION OF THIS TOTAL JOINT. SHE PRESENTS NOW WITH SEVERE MEDICAL INSTABILITY WITH A VALGUS DEFORMITY ON THE LEFT. SHE ALSO HAS SEVERE PAIN. SHE IS ADMITTED TO THIS FACILITY FOR A REVISION OF THE LEFT TOTAL KNEE. INTRAOPERATIVELY ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant TOTAL KNEE COMPONENTS GCZ ZIMMER * 57645900

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R