BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP INSTRUMENTS

    MDR report key: 23166789 · Received September 29, 2025

    Report

    Report Number
    3005180920-2025-00965
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 SEPTEMBER 2025. LOT 1112087AA-SN0(B)(6): (B)(4) ITEM MANUFACTURED AND RELEASED ON 10-JUL-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. CONCLUSIONS: SPECIFIC PATIENT CONDITIONS AND UNIQUE SURGICAL FACTORS LIKELY RESULTED IN THE ISSUE REPORTED. 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

    PRIMARY SURGERY PERFORMED ON (B)(6) 2025. THE PATIENT EXPERIENCED PAIN IN THE LOWER LEG IMMEDIATELY AFTER SURGERY. ALTHOUGH THE CONDITION WAS MONITORED, THE PAIN DID NOT IMPROVE; THEREFORE, AN X-RAY WAS PERFORMED. THE X-RAY REVEALED THREE FRACTURES: A SPIRAL FRACTURE OF THE DISTAL TIBIA; A FRACTURE OF THE PROXIMAL FIBULA, AND A FRACTURE OF THE DISTAL FIBULA (LATERAL MALLEOLUS). ACCORDING TO THE SURGEON, THESE FRACTURES MAY HAVE BEEN CAUSED BY THE MANIPULATION OF THE LEG POSITIONER DURING EXTERNAL ROTATION AND EXTERNAL ROTATION COMBINED WITH EXTENSION. INTRAMEDULLARY NAILING OF THE LOWER LEG WAS PERFORMED ON (B)(6) 2025. ADDITIONAL INFO REGARDING THE BONE QUALITY OF THE PATIENT: XRAYS ARE NOT AVAILABLE BUT IT HAS BEEN REPORTED THAT THE CORTICAL BONE APPEARS THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409849 HIP INSTRUMENTS AMIS MOBILE LEG POSITIONER 2.0 FRAME FWX MEDACTA INTERNATIONAL SA 01.15.10.0190 1112087AA-SN0471

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention