BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 22781805 · Received August 12, 2025

    Report

    Report Number
    3005180920-2025-00768
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 23, 2015
    Report Date
    September 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JULY 2025 LOT 123308: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. A REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 YEARS AFTER THE IMPLANTATION OF A THA. THE PATIENT PRESENTED WITH PAIN AND UNDERWENT A FOLLOW-UP X-RAY, WHICH REVEALED EVIDENCE OF STEM LOOSENING. THE AVAILABLE IMAGING CLEARLY CONFIRMS THIS DIAGNOSIS, SHOWING RADIOLUCENT LINES AROUND THE STEM. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE, OFTEN ARISING FROM MULTIFACTORIAL OR UNCLEAR ETIOLOGIES. IN THIS CASE AS WELL, THE PRECISE CAUSE OF FAILURE REMAINS DIFFICULT TO ESTABLISH BASED ON THE INFORMATION AVAILABLE. VISUAL INSPECTION PERFFORMED BY R6D PROJECT MANAGER. DURING THE ANALYSIS IT IS VISIBLE THE EXPIANTED STEM. THERE ARE NO HA RESIDUALS ON THE STEM BODY. ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE THAT METABOLIC ACTIVITY WAS TAKING PLACE AND THAT, PRESUMABLY, ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. THE POST-OP X-RAY ANALYSIS COULD POSSIBLY PROVIDE MORE INSIGHT, SUCH AS THE EVALUATION OF POSSIBLE EARLY ROTATIONAL INSTABILITY OR INITIAL STRESS-SHIELDING. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE NECK OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM LOOSENING REPORTED. CONCLUSION: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY KNEE ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    REVISION AT ABOUT 9 YEARS AND 8 MONTHS AFTER PRIMARY FOR STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887958 AMISTEM H FEMORAL STEMS AMISTEM H CEMENTLESS STEM STANDARD SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.133 123308 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention