BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED HA COATED LAT STEM SIZE 3

    MDR report key: 18984933 · Received March 27, 2024

    Report

    Report Number
    3005180920-2024-00138
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804687
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-MAR-2024. LOT 133965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: REVISION 9 YEARS AND 4 MONTHS AFTER PRIMARY THA DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. FROM THE RADIOGRAPHIC IMAGE, SIGNS OF STRESS SHIELDING AND RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 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 · 0

    AT ABOUT 9 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985085 AMISTEM COLLARED HA COATED LAT STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 133965 07630030804687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention