BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3

    MDR report key: 18198423 · Received November 23, 2023

    Report

    Report Number
    3005180920-2023-00895
    Event Type
    Injury
    Date Received
    November 23, 2023
    Date of Event
    October 24, 2023
    Report Date
    November 23, 2023
    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 · 0

    BATCH REVIEW PERFORMED ON 27 OCTOBER 2023: LOT 132224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2013. EXPIRATION DATE: 2018-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION PERFORMED 10 YEARS AFTER THE PRIMARY THA SURGERY, DUE TO ASEPTIC LOOSENING OF THE STEM. IN THE RADIOGRAPHIC IMAGE PROVIDED, SIGNS OF STRESS SHIELDING AND RADIOLUCENT LINES IN GRUEN ZONES 1 AND 2 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. ANALYSIS PERFORMED BY R&D MANAGER: LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IT IS VISIBLE BOTH THE EXPLANTED STEM CONNECTED WITH CERAMIC FEMORAL HEAD. THEIR SURFACES ARE COVERED WITH PATIENT BLOOD. IT SEEMS THAT NO HA RESIDUALS ARE PRESENT ON THE STEM BODY. NO PARTICULARITY ARE VISIBLE FROM THE IMAGES. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED STEM LOOSENING.

    Description of Event or Problem · 0

    ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, A REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE STEM. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240735 STEM: AMISTEM H 01.18.133 HA COATED STD STEM SIZE 3 HIP COATED STD STEM LZO MEDACTA INTERNATIONAL SA 132224 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention