BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 24924647 · Received April 20, 2026

    Report

    Report Number
    3005180920-2026-00330
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 MARCH 2026. STEM: AMISTEM H 01.18.132 AMISTEM-H STD. SIZE 2 (K093944) LOT 152209: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUL-2015. EXPIRATION DATE: 08-JUL-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. CLINICAL EVALUATION MORE THAN 10 YEARS AFTER PRIMARY CEMENTLESS DM THA, THE LADY PATIENT IS SUFFERING FROM A SUBSIDED STEM AND REVISION SURGERY IS UNDERTAKEN. THE IMAGE SUPPLIED IS PARTIAL AND LOW QUALITY AND DOES NOT ALLOW PROPER EVALUATION; IT SEEMS THAT THE STEM IS UNDERSIZED, AND THIS MAY BE DUE TO WIDENING OF THE FEMORAL CANAL OR TO OSTEOLYTIC BONE RESPONSE, BUT THE PARTIAL IMAGE DOES NOT ALLOW PROPER EVALUATION. WITH THE INFORMATION AT HAND, WE CANNOT MAKE A DEFINITIVE STATEMENT AS TO THE CAUSES OF THIS LATE ADVERSE EVENT. ROOT CAUSE: BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. MORE THAN 10 YEARS AFTER PRIMARY CEMENTLESS DM THA, STEM SUBSIDENCE OCCURRED REQUIRING REVISION; HOWEVER, THE LIMITED AND LOW-QUALITY IMAGING DOES NOT ALLOW PROPER EVALUATION. WHILE FACTORS SUCH AS STEM UNDERSIZING OR BONE CHANGES MAY BE INVOLVED, NO CLEAR DEVICE-RELATED ISSUE OR MANUFACTURING NONCONFORMITY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    AT ABOUT 10 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE PATIENT REPORTED NO TRAUMA. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA LINER AND 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
    510856 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.18.132 152209 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention