BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STEM SIZE 5 LAT

    MDR report key: 4143530 · Received September 5, 2014

    Report

    Report Number
    3006639916-2014-00119
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE SURGEON DID THE FIRST REVISION SURGERY WHERE HE TOOK OUT A STEM OF ANOTHER COMPANY IMPLANTING AN AMISTEM C. HE THOUGH EVERYTHING WAS OK, BUT LATER ON, HE REALISED THERE WAS A PROXIMAL FEMUR FRACTURE. HE DID A SECOND REVISION ON (B)(6) WHERE HE TOOK OUT THE AMISTEM AND THE BALL HEAD IMPLANTING A REVISION STEM WITH A NEW CRCO BALL HEAD. MFR REF # 3005180920-2014-00119.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544915 AMISTEM C CEMENTED STEM SIZE 5 LAT FEMORAL CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 103120

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention