BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT

    MDR report key: 14486034 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00399
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 27, 2022
    Report Date
    September 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885013
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2022: LOT 2102623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2021. EXPIRATION DATE: 2026-06-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP HAS BEEN SENT IN ORDER TO CORRECT DATA ABOUT: PRODUCT DETAILS, EVENT DESCRIPTION, BATCH REVIEW AND TO REPORT THE CLINICAL EVALUATION ANALYSIS. BATCH REVIEW PERFORMED ON 03 AUGUST 2022 LOT 1901220: 30 ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2019. EXPIRATION DATE: 2024-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 3 MONTHS AFTER THE PRIMARY THA IN A MALE PATIENT DUE TO PAIN. AFTER FEW DAYS FROM THE INDEX SURGERY A REVISION OCCURED DUE TO A PERIPROSTHETIC FRACTURE. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD AS SHOWN IN THE RADIOGRAPHIC IMAGES PROVIDED. ACCORDING TO REPORT, A SECOND REVISION WAS DONE DUE TO SUBSIDENCE OF THE STEM. NO IMAGES ARE PROVIDED AFTER THE SUBSIDENCE AND THE CAUSE IS UNKNOWN. IT MAY BE POSSIBLE THAT THE CERCLAGE COULD NOT HOLD THE LOADS OR THAT, DURING THE HEALING PROCESS, THE DIMENSIONS OF THE FEMORAL CANAL CHANGED SLIGHTLY AND WERE NO LONGER ABLE TO SUSTAIN THE STEM. AS TO THE QUESTION CONTAINED IN THE REPORT THAT AN ANGLE OF 2 ° CAN BE NOT ADEQUATE FOR THIS PURPOSE, THE LITERATURE AND MEDICAL EXPERIENCE OF THE LAST 33 YEARS HAS SHOWN THAT THIS DESIGN IS PERFECTLY SUITABLE FOR THIS PURPOSE, SO IT IS NOT A MATTER OF CONCERN. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 03 AUGUST 2022 ON STEM: M-VIZION 01.22.427 PROXIMAL BODY Ø24MM L 40MM LAT WITH HOLES (K201471) LOT. 2008338: 21 ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2021. EXPIRATION DATE: 2026-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517665 STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT HIP DISTAL STEM LZO MEDACTA INTERNATIONAL SA 01.36.168 1901220 07630030885013

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention