BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 7

    MDR report key: 9726276 · Received February 19, 2020

    Report

    Report Number
    3005180920-2020-00069
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804236
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 18 FEBRUARY 2020: LOT 111711: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2011. EXPIRATION DATE: 2016-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT (STEM AND HEAD) REVISION PERFORMED 8 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN AN ELDERLY ((B)(6) YEAR OLD) MAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, REGIONS OF REDUCED BONE DENSITY AROUND THE PROXIMAL PROFILE OF THE STEM AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED LONG-TERM ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: PRELIMINARY VISUAL INVESTIGATION HIGHLIGHTS RESIDUAL HA ON PROXIMAL FEMORAL STEM AND SIGNS OF OSSEOINTEGRATION ON DISTAL STEM.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO STEM LOOSENING, STEM AND HEAD REVISED. PRIMARY WAS PERFORMED IN (B)(6) 2012. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193747 STEM: AMISTEM H HA COATED LAT STEM SIZE 7 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.147 111711 07630030804236

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention