BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 24776967 · Received April 3, 2026

    Report

    Report Number
    3005180920-2026-00275
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720106
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 MARCH 2026. LOT 2111612: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2021. EXPIRATION DATE: 30-NOV-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A LITTLE OVER 2 YEARS SINCE PRIMARY CEMENTLESS THA, THE STEM IS COMPLETELY MOBILIZED, WITH CLEAR DEMARCATION LINES ALL AROUND VISIBLE IN THE RADIOGRAPHS. NO POST-PRIMARY IMAGES WERE SUPPLIED, SO WE CANNOT TELL ABOUT THE EVOLUTION OF THE PROBLEM AND WE CANNOT ASSESS THE PRIMARY IMPLANTATION. WITH THE INFORMATION AVAILABLE, WE SHOULD CATEGORIZE THIS EVENT AS A CASE OF IDIOPATHIC ASEPTIC LOOSENING, ALSO BECAUSE NO INFORMATION ON EXAMS AIMED AT VERIFYING THE ABSENCE OF PATHOGENES WAS GIVEN. NO FINAL CONCLUSION CAN BE DRAWN. ANALYSIS PERFORMED BY R&D PROJECT MANAGER: FROM THE INFORMATION REPORTED AND THE IMAGE ATTACHED TO THE COMPLAINT IT IS VISIBLE THE EXPLANTED STEM COVERED WITH PATIENT BLOOD. ALSO, THE EXPLANTED CERAMIC HEAD IS VISIBLE WITH SOME SCRATCHES PROBABLY DUE REVISION SURGERY. LOOKING AT THE STEM BODY, AN OPAQUE WHITE FILM IS VISIBLE ON APPROXIMATELY HALF OF THE STEM LENGTH. IT IS NOT POSSIBLE TO IDENTIFY IF THIS FILM IS HA OR BONE RESIDUAL, OR A COMBINED EFFECT. ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE THAT METABOLIC ACTIVITY WAS TAKING PLACE AND THAT, PRESUMABLY, ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. THE POST-OP X-RAY ANALYSIS COULD POSSIBLY PROVIDE MORE INSIGHT, SUCH AS THE EVALUATION OF POSSIBLE EARLY ROTATIONAL INSTABILITY OR INITIAL STRESS-SHIELDING. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE NECK OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM LOOSENING REPORTED. ROOT CAUSE:ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. WITH THE INFORMATION AVAILABLE, WE SHOULD CATEGORIZE THIS EVENT AS A CASE OF IDIOPATHIC ASEPTIC LOOSENING, ALSO BECAUSE NO INFORMATION ON EXAMS AIMED AT VERIFYING THE ABSENCE OF PATHOGENES WAS GIVEN. NO FINAL CONCLUSION CAN BE DRAWN. 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 OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO STEM LOOSENING ABOUT 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434827 AMISTEM-P AMISTEM-P LAT. SIZE1 LZO MEDACTA INTERNATIONAL SA 01.18.411 2111612 07630040720106

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention