BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 8478391 · Received April 3, 2019

    Report

    Report Number
    3005180920-2019-00227
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 1, 2019
    Report Date
    April 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 APRIL 2019: LOT 170012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2017. EXPIRATION DATE: 2022-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY MEDACTA R&D PROJECT MANAGER: VISUAL INSPECTION SHOWS HA LAYER NOT ABSORBED ON THE PROXIMAL REGION. THIS IS IN LINE WITH THE LOOSENING DIAGNOSIS. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT REVISION SURGERY OCCURRED 2 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) MAN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONE 1 AND SIGNS OF STRESS SHIELDING. NO INFORMATION CONCERNING COMORBIDITIES AND GENERAL PATIENT HEALTH IS AVAILABLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS THA AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 11 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272541 STEM: AMISTEM H HA COATED STD STEM SIZE 3 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 170012 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention