BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL CEMENTED STEM SIZE 5 STD

    MDR report key: 3883023 · Received June 4, 2014

    Report

    Report Number
    3006639916-2014-00065
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS COMPLAINING OF PAIN AND THE SURGEON DETERMINED THAT THE STEM HAD BECOME LOOSE. THE BONE AND THE CEMENT DID NOT ADHERE TO ONE ANOTHER WHICH CAUSED THE STEM TO LOOSEN. THIS IS THE PTS 4TH REVISION SURGERY DUE TO COMPLICATED MEDICAL HISTORY. REF. MFR #3005180920-2014-00065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325652 AMISTEM C FEMORAL CEMENTED STEM SIZE 5 STD FEMORAL CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 121548

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention