BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPLUS TIBIAL INSERT, 10 MM

    MDR report key: 14858 · Received July 25, 1994

    Report

    Report Number
    MW1002928
    Event Type
    Injury
    Date Received
    July 25, 1994
    Date of Event
    February 1, 1994
    Report Date
    July 14, 1994
    Manufacturer
    ORTHOMET, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    60-YR-OLD FEMALLE HAD RIGHT TOTAL KNEE REPLACEMENT 7/28/92. EARLY IN 1994 PT HAD INCREASE SYMPTOMS OF PAIN AND MECHANICAL INSTABILITY. X-RAYS SHOW TIBIAL INSERT TO BE SEPARATED FROM THE TIBIAL TRAY. REVISION OF HDPE TIBIAL INSERT WAS COMPLETED 7/13/94. REVISED INSERT SHOWED FRACTURE AT CENTER OF THIS ACL-RETAINING COMPONENT WITH EXCESSIVE WEAR POSTEROLATERAL ASPECT. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPLUS TIBIAL INSERT, 10 MM Implant TIBIAL INSERT HSH ORTHOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R