BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H STANDARD SIZE 3

    MDR report key: 8353660 · Received February 20, 2019

    Report

    Report Number
    3005180920-2019-00072
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    January 21, 2019
    Report Date
    February 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    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 ON 18 FEBRUARY 2019: LOT 113186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2011. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER REVISION SURGERY OCCURRED 5 YEARS AND 3 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONE 1 AND SIGNS OF STRESS SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS HIP REPLACEMENTS AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 5 YEARS AND 3 MONTHS FROM THE PRIMARY DUE TO ASEPTIC STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148288 AMISTEM H STANDARD SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 113186 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention