BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL FEMORAL COMPONENT LANSING CUSTOM KNEE

    MDR report key: 161384 · Received February 20, 1998

    Report

    Report Number
    1832656-1998-00002
    Event Type
    Injury
    Date Received
    February 20, 1998
    Date of Event
    December 17, 1997
    Report Date
    February 19, 1998
    Manufacturer
    BIOPRO, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ROTATION DEVICE ON THE FEMORAL COMPONENT CRACKED. THIS MAY HAVE OCCURRED WHEN THE PT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL FEMORAL COMPONENT LANSING CUSTOM KNEE Implant CONSTRAINED FEMORAL KNEE HSA BIOPRO, INC. NA M011870

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization