BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 22381440 · Received July 2, 2025

    Report

    Report Number
    3005180920-2025-00569
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 3, 2025
    Report Date
    July 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720021
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-JUNE-2025: LOT 2112757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-03-2022 EXPIRATION DATE: 2027-02-21. 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. INSPECTION PERFORMED BY R&D DEPARTMENT: LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IT IS VISIBLE THE EXPLANTED STEM COVERED WITH PATIENT BLOOD. ON THE STEM BODY AN OPAQUE WHITE FILM IS VISIBLE ON APPROXIMATELY HALF OF THE STEM LENGTH. IT IS NOT POSSIBLE TO IDENTIFY IF THIS FILM IS HA OR BONE RESIDUAL, OR A COMBINED EFFECT. THE INSPECTION OF THE RETURNED DEVICE CONFIRMED THIS, ALSO IT IS NOTICEABLE THAT NO RESIDUE IS PRESENT ON THE DISTAL PART OF THE STEM. 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 SHOW RADIOLUCENCIES ON THE POXIMAL PART CONFIRMING THAT THE STEMS WAS NOT CORRECTLY ONSTEOINTEGRATED ON THE PROXIMAL PART, CAUSING INITIAL STRESS-SHIELDING. FINALLY, 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. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT A REVISION SURGERY WAS PERFORMED APPROXIMATELY THREE YEARS AFTER THE PRIMARY TOTAL HIP ARTHROPLASTY DUE TO ASEPTIC STEM LOOSENING. THE PATIENT REPORTED PERSISTENT PAIN AND A LIMPING GAIT. AVAILABLE RADIOGRAPHIC IMAGES DEMONSTRATE EVIDENT RADIOLUCENT LINES, PARTICULARLY IN THE TROCHANTERIC REGION, ACCOMPANIED BY CORTICAL THICKENING IN THE DISTAL FEMUR. ASEPTIC LOOSENING IS A WELL-RECOGNIZED COMPLICATION IN THE LITERATURE, OFTEN RESULTING FROM MULTIFACTORIAL OR IDIOPATHIC MECHANISMS. IN THIS CASE, THE EXACT ETIOLOGY OF THE FAILURE CANNOT BE CONCLUSIVELY DETERMINED BASED ON THE AVAILABLE CLINICAL AND RADIOLOGICAL DATA. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT PRIMARY HIP SURGERY IN (B)(6) 2022. POSTOP OUTCOME NORMAL, PATIENT SATISFIED. SINCE JANUARY 2024 THE PATIENT REPORTED THIGH PAIN AND LIMPING. ASEPTIC LOOSENING DETECTED ON RADIOLOGICAL EXAMINATION. REVISION OPERATION PERFORMED ON (B)(6) 2025. STEM WAS REMOVED VIA POSTERIOR APPROACH AND AN AMISTEM-C SIZE 4 STD STEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328072 AMISTEM-P AMISTEM-P STD. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.403 2112757 07630040720021

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention