BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM CEMENTLESS

    MDR report key: 2163455 · Received July 6, 2011

    Report

    Report Number
    3005180920-2011-00033
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON PERFORMED THE PRIMARY SURGERY ON THE (B)(6) 2011: FROM THE POST-OP X-RAYS, HE NOTICED THE FRACTURE OF THE FEMUR, SO HE BROUGHT BACK THE PATIENT INTO THE THEATRE AND CHANGED THE STEM WITH A NEW CEMENTED STEM. THE MANUFACTURING DOCUMENTS (BATCH RECORD) OF THE HA COATED STEM SIZE 7 WERE REVIEWED: ALL THE VALUES WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS IN FORCE AT THE TIME OF PRODUCTION. (B)(4). TO DATE 8 STEMS WERE IMPLANTED AND NO OTHER SIMILAR EVENTS WERE REPORTED. THERE ARE NO EVIDENCES THAT THE FRACTURE IS DEVICE RELATED; THIS INJURY IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    THE PATIENT HAD A FEMUR FRACTURE. THE SURGEON NOTICED THE PROBLEM CHECKING THE POST OP X-RAYS, THEN HE BROUGHT BACK THE PATIENT INTO THE THEATRE AND REVISED THE STEM WITH A NEW ONE, CEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM CEMENTLESS FEMORAL STEM SIZE 7 STANDARD LZO MEDACTA INTERNATIONAL, SA 103210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention