BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 25012251 · Received April 28, 2026

    Report

    Report Number
    3005180920-2026-00361
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720229
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 APRIL 2026 STEM: AMISTEM-P COLLARED 01.18.433 AMISTEM-P COLLARED STD. SIZE 3 (K173794) LOT 2418858: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2024. EXPIRATION DATE: 09-OCT-2029. 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 ONE YEAR AFTER PRIMARY CEMENTLESS THA THE STEM IS LOOSE AND NEEDS REVISION. THE QUALITY OF THE RADIOGRAPHIC IMAGE IS SUCH THAT NO CONCLUSION CAN BE DRAWN FROM ITS ANALYSIS. APPARENTLY, THE HOST BONE NEVER INTEGRATED THE STEM. THIS IS PROBABLY A CASE OF EARLY IDIOPATHIC ASEPTIC LOOSENING, UNEXPLAINED. WE SEE NO REASON TO SUSPECT A FAULTY OR DEFECTIVE DEVICE. ROOT CAUSE: ASEPTIC LOOSENING IS 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 AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF A FALL OR TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518701 AMISTEM-P COLLARED AMISTEM-P COLLARED STD. SIZE3 LZO MEDACTA INTERNATIONAL SA 01.18.433 2418858 07630040720229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention