BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP INSTRUMENTS

    MDR report key: 21847223 · Received April 16, 2025

    Report

    Report Number
    3005180920-2025-00365
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    March 21, 2025
    Report Date
    May 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: TEST ON THE SHOE AND LEG POSITIONER USED IN THE SURGERY OF THE COMPLAINT: - THE PIN OF THE SHOE WAS DAMAGED ON THE BLACK PLASTIC PART AND UNSCREWED BY SOMEONE OUTSIDE MEDACTA FACILITIES. - THE COMPLAINT SHOE/TABLE DISCONNECTION ROOT CAUSE IS THIS UNSCREWING THAT HAS REDUCED THE PIN LENGTH AND ALLOWED THE SHOE PIN TO COME OUT FROM THE RETAINING HOLE PRESENT ON THE LEG POSITIONER PART IN CONNECTION WHEN THE PATIENT'S LEG IS PUT ON EXTERNAL ROTATION. TEST DONE BETWEEN A COMPLIANT SHOE AND THE SAME LEG POSITIONER USED IN THE SURGERY OF THE COMPLAINT: MAKING SOME TESTS BETWEEN A COMPLIANT SHOE WITH THE SAME LEG POSITIONER USED IN THE SURGERY OF THE COMPLAINT, WE DID NOT NOTICE ANY PROBLEM OR UNEXPECTED DISCONNECTION. THE PIN OF THE SHOE IS FIXED WITH A THREADED LOCKER (FIXED WITH LOCTITE) TO MAKE IT DIFFICULT TO UNSCREW THE PIN AND AVOID UNEXPECTED UNSCREWING. FUNCTIONAL CONTROLS ARE ALWAYS MADE BY THE MEDACTA CQ DEPARTMENT ON EVERY SHOE BEFORE SHIPMENT. CONCLUSIONS: AS REPORTED IN THE INVESTIGATION THE ROOT CAUSE OF THE EVENT IS THAT THE PIN OF THE SHOE WAS DAMAGED ON THE BLACK PLASTIC PART AND UNSCREWED BY SOMEONE OUTSIDE MEDACTA FACILITIES LEADING TO A POOR CONNECTION STABILITY WITH THE AMIS MOBILE LEG POSITIONER. FUNCTIONAL CONTROLS ARE ALWAYS MADE BY THE MEDACTA CQ DEPARTMENT ON EVERY SHOE BEFORE SHIPMENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 MARCH 2025: LOT 2158139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING SURGERY, WHILE EXTERNAL ROTATING THE FOOT WHEN THE LEG WAS DOWN, THE BOOT SLIPPED AWAY FROM THE AMIS MOBILE LEG POSITIONER. THIS WAS DUE TO THE BOOT CLIPPING MECHANISM TO THE AMIS MOBILE LEG POSITIONER. A BONE FRACTURE WAS DETECTED IN PER-OP, BUT THE SURGEON IS NOT SURE IF THIS WAS DUE TO THE BOOT SLIPPING AWAY OR TO THE PREPARATION OF THE FEMUR WITH COMPETITOR BROACHES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126976 HIP INSTRUMENTS AMIS SHOE FWX MEDACTA INTERNATIONAL SA 01.15.10.0315 2158139

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention