BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 24738813 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00265
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 MARCH 2026. STEM: AMISTEM H 01.18.133 AMISTEM-H STD. SIZE 3 (K093944) LOT 152523: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2015. EXPIRATION DATE: 13-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. BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 151164: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-AUG-2015. EXPIRATION DATE: 30-JUN-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. ROOT CAUSE: 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 DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE PATIENT HAD PRIMARY SURGERY FOR A FEMUR FRACTURE AND THAT WAS THE SITE OF THE PAIN. ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE AMISTEM SIZE 3 TO A SHORTER SMS SOLID STEM SIZE 9, AND REVISED THE 36MM BIOLOX HEAD M TO A 36MM BIOLOX HEAD L. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802912 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.133 152523 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention