BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23864305 · Received December 22, 2025

    Report

    Report Number
    3005180920-2025-01314
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 10 YEARS AFTER PRIMARY CEMENTLESS THA, AREAS OF PROGRESSIVE BONE RAREFACTION ARE VISIBLE ON THE ONE X-RAY SUPPLIED. ORIGIN UNKNOWN. THE RESULT IS A PROGRESSIVELY LOOSE STEM THAT REQUIRES EXCHANGE. NO OTHER SIGNIFICANT FINDINGS WERE REPORTED FROM THE REVISION SURGERY. IN THE ABSENCE OF TRAUMA OR INFECTION, WE MUST CLASSIFY THIS EVENT AS A CASE OF IDIOPATHIC ASEPTIC LOOSENING, WHICH IS ONE OF THE LONG-TERM ADVERSE EVENT THAT MAY OCCUR AFTER TOTAL JOINT ARTHROPLASTY. BATCH REVIEW PERFORMED ON 18 DECEMBER 2025. LOT: 140745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2015. EXPIRATION DATE: 29-FEB-2020. 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. ROOT CAUSE:IN THE ABSENCE OF TRAUMA OR INFECTION, WE MUST CLASSIFY THIS EVENT AS A CASE OF IDIOPATHIC ASEPTIC LOOSENING, WHICH IS ONE OF THE LONG-TERM ADVERSE EVENT THAT MAY OCCUR AFTER TOTAL JOINT ARTHROPLASTY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 10 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN RELATED TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO SIGNS OF TRAUMA. THE SURGEON SWAPPED THE MEDACTA HEAD AND STEM FOR A COMPETITOR HEAD AND STEM AND SWAPPED THE MEDACTA LINER FOR A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257824 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 1 LZO MEDACTA INTERNATIONAL SA 01.18.131 140745 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention