BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 22674986 · Received July 31, 2025

    Report

    Report Number
    3005180920-2025-00754
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263574
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JULY 2025: STEM: M-VIZION 01.22.408 PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES (K201471) LOT. 2010781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUG 2021. EXPIRATION DATE: 19 AUG 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED, BATCH REVIEW PERFORMED ON 29 JULY 2025: BALL HEADS: COCR 01.25.023 CRCO BALL HEAD 12/14 Ø 32SIZE L +3.5 (K072857) LOT. 180326: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APR 2018. EXPIRATION DATE: 10 APR 2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CUP: MPACT 01.32.150MH MPACT MULTI HOLE CUP 50MM (K132879) LOT. 2011718: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MARCH 2021. EXPIRATION DATE: 02 MARCH 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HC10A FACE-CHANGING 10° PE HC LINER Ø32/D(K183582) LOT. 1810848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2019. EXPIRATION DATE: 03 MARCH 2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JULY 2025: STEM: M-VIZION 01.22.408 PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES (K201471) LOT. 2010781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 SEP 2021. EXPIRATION DATE: 19 AUG 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED, BATCH REVIEW PERFORMED ON 29 JULY 2025: BALL HEADS: COCR 01.25.023 CRCO BALL HEAD 12/14 Ø 32SIZE L +3.5 (K072857) LOT. 180326: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APR 2018. EXPIRATION DATE: 10 APR 2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CUP: MPACT 01.32.150MH MPACT MULTI HOLE CUP 50MM (K132879) LOT. 2011718: 40 ITEMS MANUFACTURED AND RELEASED ON 12 MARCH 2021. EXPIRATION DATE: 02 MARCH 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HC10A FACE-CHANGING 10° PE HC LINER Ø32/D(K183582) LOT. 1810848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2019. EXPIRATION DATE: 03 MARCH 2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE. FOLLOW UP - REASON: - ON 29 AUGUST 2025, WE NOTICED THAT THE MANUFACTURING DATE (H4) OF THE M-VIZION 01.22.408 PROXIMAL BODY Ø20 MM L 50 MM LAT WITH HOLES LOT 2010781 WAS INCORRECT AND WE CORRECTED IT. - E4 CORRECTED.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 10 MONTHS FROM PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 10 MONTHS FROM PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49654 M-VIZION FEMORAL REVISION SYSTEM PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.408 2010781 07630971263574

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention