BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COLLARED FEMORAL STEMS

    MDR report key: 23579772 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01110
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804663
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2025. STEM: AMISTEM H 01.18.241 AMISTEM COLLARED HA COATED STEM SIZE 1 LAT (K121011) LOT 133239: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2013. EXPIRATION DATE: 31-AUG-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION 11 YEARS AFTER PRIMARY CEMENTLESS THA, THE STEM IS MOBILIZED AND REQUIRES REVISION. THERE IS ONLY ONE RADIOGRAPH SUPPLIED, WHICH DOES NOT ALLOW TO RECONSTRUCT CASE HISTORY AND DETERMINE WHEN THE PROBLEMS STARTED. WE CAN SEE THAT IN GRUEN ZONE 1 THE STEM IS CLEARLY DETACHED FROM THE BONE ON THE PRE-REVISION XRAY, AND THIS LACK OF PROXIMAL CONSTRAINT LED THE LOAD TRANSMISSION TO TAKE PLACE MOSTLY AT DISTAL LEVEL, WHICH IN TURN RESULTED IN CORTICAL THICKENING AND EVENTUALLY PAIN. THE CANAL HAS PROBABLY WIDENED OVER TIME, BECAUSE THE STEM NOW LOOKS RATHER SMALL (NO LATERAL PROJECTION AVAILABLE - THIS MAY INDUCE IN ERROR), BUT ORIGINALLY THE SIZING MUST HAVE BEEN CORRECT AS THE DISTANCE BETWEEN COLLAR AND RESECTION SHOWS THAT NO INITIAL SUBSIDENCE TOOK PLACE. THE ROOT CAUSE OF THE LOOSENING IS THEREFORE PROBABLY CANAL WIDENING/BONE DEPAUPERATION OVER TIME, OR IT CAN BE ASCRIBED TO A CASE OF IDIOPATHIC ASEPTIC LOOSENING. ROOT CAUSE: 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. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 10 YEARS AND 10-MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER TO MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862806 AMISTEM H COLLARED FEMORAL STEMS AMISTEM COLLARED HA COATED STEM SIZE 1 LAT LZO MEDACTA INTERNATIONAL SA 01.18.241 133239 07630030804663

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention