BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 591940 · Received April 15, 2005

    Report

    Report Number
    1822565-2005-00060
    Event Type
    Injury
    Date Received
    April 15, 2005
    Date of Event
    January 21, 2005
    Report Date
    January 21, 2005
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED IN 1999. AT A 5-YEAR FOLLOW-UP, PATIENT EXHIBITED OSTEOLYTIC LESIONS AT THE SCREW SHAFTS. DEVICE WAS REVISED 2005.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1999. AT A 5-YEAR FOLLOW-UP, PT EXHIBITED OSTEOLYTIC LESIONS AT THE SCREW SHAFTS. DEVICE WAS REVISED 2005.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED ON 05/26/1999. AT A 5-YEAR FOLLOW-UP, PATIENT EXHIBITED OSTEOLYTIC LESIONS AT THE SCREW SHAFTS. DEVICEWAS REVISED 1/21/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM CONGRUENT TIBIAL INSERT KNEE PROTHESIS JWH ZIMMER, INC. NA 1375971

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R