BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23036834 · Received September 12, 2025

    Report

    Report Number
    3005180920-2025-00853
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030804236
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 10 YEARS AFTER PRIMARY CEMENTLESS THA A FEMORAL FRACTURE OCCURS. LOOKING AT THE XRAYS, A TRAUMATIC EVENT IS TO BE SURMISED, EVEN THOUGH IT'S NOT EXPLICITLY MENTIONED IN THE REPORT. THE STEM APPEARS TO BE WELL FIXED AND THE FEMORAL BONE NOT SIGNIFICANTLY ALTERED. NO REASON TO SUSPECT A MALFUNCTIONING OR DEFECTIVE DEVICE. BATCH REVIEW PERFORMED ON 26 AUGUST 2025: LOT: 120928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2012. EXPIRATION DATE: 2017-05-31. 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 (RESTERILIZED ITEMS ALSO CONSIDERED). 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

    THE PATIENT HAD A PERIPROSTHETIC FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. AT ABOUT 10 YEARS AND 3 MONTHS POST PRIMARY, THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330814 AMISTEM H FEMORAL STEMS AMISTEM H CEMENTLESS STEM LATERALIZED SIZE 7 MEH MEDACTA INTERNATIONAL SA 01.18.147 120928 07630030804236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention