BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20734636 · Received November 20, 2024

    Report

    Report Number
    3005180920-2024-00956
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040729116
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-OCT-2024: LOT 2200650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2022. EXPIRATION DATE: 2027-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 REVISION SURGERY WAS PERFORMED ONE MONTH AFTER IMPLANTATION OF AN M-VIZION STEM DURING A TOTAL HIP ARTHROPLASTY (THA). THE PATIENT REPORTED PAIN, AND THE AVAILABLE X-RAY IMAGES REVEAL A DISLOCATION OF THE PROSTHETIC HIP. ADDITIONALLY, THE FEMUR SHAPE APPEARS IRREGULAR, WITH CERCLAGE WIRES ALONG THE LENGTH OF THE STEM, AND THE STEM LIKELY SHOWS SIGNS OF SUBSIDENCE. DETAILS ABOUT THE INITIAL SURGERY ARE UNAVAILABLE (E.G., FRACTURE OR OSTEOTOMY), BUT IT IS POSSIBLE THAT IN SUCH A COMPLEX CASE, THE FEMORAL STEM DID NOT ACHIEVE ADEQUATE PRIMARY STABILITY, LEADING TO SUBSEQUENT SUBSIDENCE. THE OBSERVED DISLOCATION MAY HAVE OCCURRED AS A CONSEQUENCE OF THIS SUBSIDENCE. WE SEE NO REASON TO SUSPECT A DEFECTIVE DEVICE. ADDITIONAL COMPONENT INVOLVED AND REVISED: STEM: M-VIZION 01.22.405 PROXIMAL BODY Ø20MM L 80MM STD WITH HOLES (K201471) LOT 2010778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2021. EXPIRATION DATE: 2026-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M (K112115) LOT 2338625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2023. EXPIRATION DATE: 2028-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED BECAUSE IT IS NOT POSSIBLE TO RETRIEVE OTHER INFORMATION. FROM THE X-RAYS ANALYSIS, IT IS LIKELY THAT THE JOINT LUXATION AND STEM SUBSIDENCE CONTRIBUTED TO THE REPORTED ISSUE. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SURGERY WITH A COMPETITOR ON AN UNKNOWN DATE. SUBSEQUENTLY, ON THE (B)(6) 2024, THE COMPETITOR STEM AND HEAD WERE REVISED TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR IMPLANTS. SURGERY WAS COMPLETED SUCCESSFULLY. NO ISSUES DETECTED WITH IMPLANTS, ONLY PAIN WAS REPORTED. IT IS UNKNOWN WHETHER OR NOT THE COMPETITOR LINER WAS REVISED, BUT A MEDACTA LINER WAS NOT USED IN ANY SURGERY. THE DISTRICT SALES MANAGER DIDN'T HAVE ANY REPS IN THIS HOSPITAL AREA SO NO OTHER INFORMATION IS AVAILABLE. FROM THE ANALYSIS OF THE X-RAYS, IT IS VISIBLE THAT JOINT LUXATION OCCURRED. MOREOVER, THE FEMUR SHAPE APPEARS IRREGULAR, WITH CERCLAGE WIRES AND THE STEM LIKELY SHOWS SIGNS OF SUBSIDENCE, PROBABLY A RESULT OF NON-ADEQUATE PRIMARY STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433039 M-VIZION FEMORAL REVISION SYSTEM STEM: M-VIZION DISTAL STEM Ø16MM L 220MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.165 2200650 07630040729116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention