BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RET TIB COMP 72WX7.5THK

    MDR report key: 197006 · Received November 9, 1998

    Report

    Report Number
    1822565-1998-00135
    Event Type
    Injury
    Date Received
    November 9, 1998
    Date of Event
    October 6, 1998
    Product Code
    HSH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    THREE MONTHS PRIOR TO HOSPITALIZATION, PT WAS HAVING INCREASED PAIN. X-RAYS REVEALED A LOOSENED TIBIAL COMPONENT. INTRAOPERATIVELY, THE ENTIRE TOTAL KNEE COMPONENTS WERE FOUND TO BE LOOSENED. THE TOTAL KNEE COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant RET TIB COMP 72WX7.5THK HSH NA 72777700

    Patients

    Seq Age Sex Outcome Treatment
    1