BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 23864347 · Received December 22, 2025

    Report

    Report Number
    3005180920-2025-01287
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION. 12 YEARS AFTER PRIMARY CEMENTLESS THA ON A VERY YOUNG AND VERY HEAVY MALE PATIENT, THE STEM IS LOSING PROXIMAL FIXATION AND THE SURGEON DECIDES TO EXCHANGE IT. SOME SIGNS OF WEAR OF THE PE LINER ARE VISIBLE IN THE RADIOGRAPH, BUT WE CANNOT DETERMINE THE POTENTIAL INFLUENCE THAT THIS MAY HAVE HAD ON THE REVISION PROCEDURE - IN FACT, THERE ARE NO MAJOR VISIBLE AREAS OF OSTEOLYSIS AND THE BONE QUALITY SEEMS TO BE STILL VERY GOOD. THE REASON FOR THE LOOSENING CANNOT BE DETERMINED WITH THE INFORMATION AT HAND, SO WE SHOULD CLASSIFY IT AS IDIOPATHIC ASEPTIC LOOSENING. BATCH REVIEW PERFORMED ON 11 DEC 2025. STEM: AMISTEM H 01.18.143 AMISTEM-H LAT. SIZE 3 LOT. 131167: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 JUNE 2013. EXPIRATION DATE: 30 APRIL 2018. 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:ALTHOUGH A PRECISE ROOT CAUSE CANNOT BE ESTABLISHED, THE EVENT CAN BE CLASSIFIED AS IDIOPATHIC ASEPTIC LOOSENING. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY POTENTIAL MANUFACTURING-RELATED ISSUES.

    Description of Event or Problem · 0

    AFTER 12 YEARS AND 3 MONTHS POST-PRIMARY, THE PATIENT CAME IN DUE TO A POTTED STEM.THE SURGERY REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256901 AMISTEM H FEMORAL STEMS AMISTEM-H LAT. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.143 131167 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention