BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20369575 · Received October 4, 2024

    Report

    Report Number
    3005180920-2024-00812
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 7, 2024
    Report Date
    October 4, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885143
    PMA / PMN Number
    K170690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 OCTOBER 2024: LOT 2007105: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2020. EXPIRATION DATE: 2026-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 04 OCTOBER 2024: M-VIZION 01.22.10.0241 TRIAL PROXIMAL BODY Ø24MM L 40MM STD LOT 1954620: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. M-VIZION 01.22.10.0242 TRIAL PROXIMAL BODY Ø24MM L 50MM ST LOT 1954631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. M-VIZION 01.22.10.0243 TRIAL PROXIMAL BODY Ø24MM L 60MM STD LOT 1954632: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. M-VIZION 01.22.10.0227 TRIAL PROXIMAL BODY Ø20MM L 40MM LAT LOT 1854647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. LOT 1854647B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. M-VIZION 01.22.109 DISTAL STEM Ø20MM L 140MM STRAIGHT LOT 155522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MARCH-2017. EXPIRATION DATE: 2021-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. M-VIZION 01.22.108 DISTAL STEM Ø19MM L 140MM STRAIGHT (K170690) LOT 2006793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2020. EXPIRATION DATE: 2025-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. M-VIZION 01.22.107 DISTAL STEM Ø18MM L 140MM STRAIGHT (K170690) LOT 2007041: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: IMPLANTS WERE ANALYSED AND THE RESULTS ARE LISTED BELOW. - DISTAL STEM L140 Ø18 REF.01.22.107 (LOT 2007041): THE THREAD OF THE STEM WAS DAMAGED, NOT POSSIBLE TO INSERT THE SCREW, THE FIRST 3-4 THREADS ARE MISSING (REMOVED). - DISTAL STEM L140 Ø19 REF.01.22.108 (LOT 2006793): THE FIRST 3-4 THREADS ARE MISSING (REMOVED). - DISTAL STEM L140 Ø20 REF.01.22.109 (LOT 155522): THE SHAFT OF THE BROKEN SCREW WAS STILL INSIDE THE STEM HOLE, IT WAS REMOVED AND THE THREAD WAS INSPECTED AND NO MAJOR DEFECTS FOUND, IT WAS POSSIBLE TO INSERT A NEW SCREW BUT THE SCREWING WAS NOT SMOOTH. - LOCKING SCREW 01.22.201 (LOT 2007105): THE SCREW WAS FOUND BROKEN AT THE FIRST THREAD, THE FRACTURE SEEMS TO BE DUE TO EXCESSIVE TORSIONAL FORCES. THE ROOT CAUSE OF THE FAILURE IS PROBABLY DUE TO THE TREADED ROD 01.22.10.0141 THAT WAS FOUND WITH DAMAGED THREADS, THAT DAMAGED THE DISTAL STEM THREAD DURING THE ASSEMBLY PROCEDURE. THE DAMAGED STEM THREAD COULD HAVE CAUSED THE SCREW TO BREAK. TWO STEMS WERE FOUND WITH FIRST 3-4 THREADS MISSING, PROBABLY THEY WERE FIRST DAMAGED BY THE THREADED ROD AND THEN MECHNICALLY REMOVED BY THE TRIAL SCREW THAT CROSS-THREADED INTO THE STEM. NO ACTIONS HAVE BEEN IMPLEMENTED SINCE THE ROOT CAUSE IS DUE TO A PARTICULAR CONDITION HAPPENED DURING THE SURGERY. WE ARE MONITORING THE ISSUE THAT, UP TO NOW, IS AN ISOLATED CASE.

    Description of Event or Problem · 0

    DIFFERENT TRIAL PROXIMAL BODIES COULD NOT BE COUPLED WITH THE FINAL DISTAL STEM IMPLANT. AFTER MANY ATTEMPTS, THE LOCKING SCREW (IMPLANT) WAS USED TO FIX THE TRIAL PROXIMAL BODY WITH THE FINAL DISTAL IMPLANT. THE SCREW HEAD BROKE WHILE TIGHTENING WITH THE TORQUE WRENCH. THE SURGEON REMOVED THE WHOLE IMPLANT AND TOOK AN ALTERNATIVE (PRE-ASSEMBLED IN BACK-TABLE) TO COMPLETE THE SURGERY. 1H OF DELAY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443031 M-VIZION FEMORAL REVISION SYSTEM STEM LOCKING SCREW LZO MEDACTA INTERNATIONAL SA 01.22.201 2007105 07630030885143

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other