BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT

    MDR report key: 17533437 · Received August 12, 2023

    Report

    Report Number
    MW5140341
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    January 31, 2022
    Report Date
    February 16, 2022
    Manufacturer
    STRYKER INC.
    Product Code
    LOD
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355503 CEMENT BONE CEMENT LOD STRYKER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown