BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 0

    MDR report key: 10507108 · Received September 9, 2020

    Report

    Report Number
    3005180920-2020-00597
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21-AUG-2020. LOT 141457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2014. EXPIRATION DATE: 30-APR-2019. 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 SINCE 2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT (STEM, HEAD AND LINER) REVISION PERFORMED 5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM 5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973604 STEM: AMISTEM H HA COATED STD STEM SIZE 0 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.130 141457 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention