BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD SIZE 6

    MDR report key: 11568359 · Received March 25, 2021

    Report

    Report Number
    3005180920-2021-00231
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804120
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23-MAR-2021: LOT 161935: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2016. EXPIRATION DATE: 2021-06-05. 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 2017. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D DEPARTMENT: LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IS CLEARLY VISIBLE HOW THE WHOLE HA COATING OF THE STEM BODY HAS BEEN ABSORBED BY THE PATIENT BONE AS EXPECTED. NO PARTICULAR SIGNS OR SCRATCHES ARE VISIBLE ON THE STEM BODY. THE ROOT CAUSE OF REPORTED ASEPTIC LOSENING REMAINS UNKNOWN. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: FEMORAL COMPONENT REVISION PERFORMED 3 YEARS AND 4 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, 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

    REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466180 STEM: AMISTEM H HA COATED STD SIZE 6 CEMENTLES FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 01.18.136 161935 07630030804120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention