BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL STEMS

    MDR report key: 23001778 · Received September 9, 2025

    Report

    Report Number
    3005180920-2025-00847
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803857
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 AUGUST 2025. STEM: AMISTEM C 01.18.107 AMISTEM-C LAT. SIZE 7 (K103189) LOT 157364: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MARCH-2016. EXPIRATION DATE: 2021-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION 8.5 YEARS AFTER PRIMARY HYBRID THA THE STEM BECOMES LOOSE. THERE IS BASICALLY NO INFORMATION ON THIS CASE AND THE QUALITY OF THE ONE RADIOGRAPH SUPPLIED IS POOR. CEMENT MANTLE APPEARS TO BE DETACHED FROM THE BONE, BUT WITH NO HISTORY NO USEFUL COMMENT CAN BE MADE. WE OUGHT TO CATEGORIZE THIS CASE AS ASEPTIC LOOSENING, BUT NO FURTHER COMMENT CAN BE OFFERED WITH THE INFORMATION AT HAND. CONCLUSION: 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.

    Description of Event or Problem · 0

    AT ABOUT 8 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068871 AMISTEM C FEMORAL STEMS AMISTEM C CEMENTED STEM LATERALIZED SIZE 7 LZO MEDACTA INTERNATIONAL SA 01.18.107 157364 07630030803857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention