BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 23310304 · Received October 16, 2025

    Report

    Report Number
    3005180920-2025-00981
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040720212
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: 2 YEARS AFTER CEMENTLESS PRIMARY THA, AT FOLLOW UP EXAMINATION THE SURGEON NOTICES A SLIGHT CORTICAL HYPERTHROPHY IN CORRESPONDENCE WITH THE MEDIAL DISTAL END OF THE FEMORAL STEM. NO REPORT OF CLINICAL PROBLEMS. THE STEM WAS IMPLANTED IN A SLIGHTLY VALGUS POSITION. THIS MAY BE DUE TO THE ANATOMICAL SHAPE OF THE FEMUR OR OF THE HIP (WE DO NOT KNOW AS THE PREOPERATIVE IMAGES WERE NOT SUPPLIED) OR IT COULD BE A SLIGHT DEVIATION FROM THE PLANNED POSITION. IN EITHER CASE, CONTACT BETWEEN THE DISTAL MEDIAL CORTEX AND THE TIP OF THE STEM IS TAKING PLACE, AND NATURALLY A SIGNIFICANT FRACTION OF THE LOAD IS TRANSMITTED IN THAT AREA, RESULTING IN CORTICAL HYPERTROPHY. IT IS VERY LIKELY THAT THIS FINDING, PER SE, WILL NOT CREATE ANY CLINICAL PROBLEM EVEN IN THE LONG TERM. IT IS NOT DUE TO A DEFECT OR MALFUNCTION OF THE IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2025 LOT 2200406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2022. EXPIRATION DATE: 2027-05-16. 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. CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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.

    Description of Event or Problem · 0

    DURING A POSTOPERATIVE FOLLOW-UP EXAMINATION 2 YEARS AFTER PRIMARY, X-RAY IMAGING REVEALED CORTICAL HYPERTROPHY AT THE DISTAL PORTION OF THE STEM. THE PATIENT REMAINS UNDER OBSERVATION. NO REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253770 AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 2 LPH MEDACTA INTERNATIONAL SA 01.18.432 2200406 07630040720212

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other