BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESIDE ORTHOLOC II FEMOARL PROSTHESIS-DEV. 1

    MDR report key: 51443 · Received November 19, 1996

    Report

    Report Number
    1043534-1996-00035
    Event Type
    Injury
    Date Received
    November 19, 1996
    Date of Event
    September 25, 1996
    Report Date
    November 18, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: AN EVAL BY DOW CORNING PERSONNEL HAS DETERMINED THAT THIS SPECIFIC EVENT CAN BE ATTRIBUTED TO A MULTITUDE OF VARIABLES INDEPENDENT OF THE COMPONENT.

    Description of Event or Problem · 1

    PT BROUGHT TO OR 9/25/96 FOR REVISION TOTAL KNEE. POST-OP IT WAS DISCOVERED THAT THE FEMORAL COMPONENT ORIGINALLY IMPLANTED (DATE UNK) HAD FAILED AND SPLIT. SURGEON NOR PT CAN RECALL IF PT HAD FALLEN PRIOR TO OR ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESIDE ORTHOLOC II FEMOARL PROSTHESIS-DEV. 1 Implant KNEE COMPONENT JWH WRIGHT MEDICAL TECHNOLOGY, INC. NA 19350

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R