BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY CEMENT 40G X 2

    MDR report key: 2993183 · Received February 27, 2013

    Report

    Report Number
    MW5029213
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ORTHOPAEDICS, INC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DJD LEFT KNEE: WHILE MIXING THE CEMENT NOTED THE CONSISTENCY WAS NOT NORMAL. SECOND TIME IN SAME DAY (DIFFERENT CASES) THAT CEMENT DID NOT PERFORM AS EXPECTED. CEMENT EVENTUALLY HARDENED. PROLONGED ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84081 DEPUY CEMENT 40G X 2 DEPUY VISCOSITY ANTIBIOTIC BONE CEMENT NDN ORTHOPAEDICS, INC. 3480149

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention