M-Vizion Femoral Revision System 01.22.408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971263574), received between Mar 27, 2025 and Jul 31, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  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.

  Patient problems: Medical device site infection

  MAUDE report 22674986 ↗
• InjuryJul 29, 2025Positioning Problem; Positioning Problem

  AT ABOUT 1 WEEK FROM PRIMARY THE PATIENT UNDERWENT REVISION SURGERY DUE TO A MALPOSITIONING OF THE DISTAL STEM (FALSA VIA). THE ENTIRE CONSTRUCT HAS BEEN REVISED. THE TWO PARTS COULD NOT BE SEPARATED AS THE TIP OF THE SCREWDRIVER USING DURING PRIMARY BROKE INSIDE THE LOCKING SCREW. DURING THE TIGHTENING OF THE LOCKING SCREW THE SCREW DRIVER TIP BROKE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22643026 ↗
• InjuryMar 27, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  M-VIZION STEM WAS IMPLANTED ON (B)(6) 2025. THE PATIENT NEEDED TO BE REVISED BECAUSE WAS EXPERIENCING PAIN, INSTABILITY AND LEG LENGTH DISCREPANCY, DUE TO A TOO SHORT PROXIMAL BODY IMPLANTED AT THE PRIMARY SURGERY. THE REVISION SURGERY TOOK PLACE 1 MONTH AFTER THE PRIMARY SURGERY AND THE PLAN WAS TO REVISE ONLY THE PROXIMAL BODY. HOWEVER, THE DISASSEMBLY ROD BENT DURING PROXIMAL STEM EXTRACTION FROM THE DISTAL BODY. DESPITE THE ATTEMPTS, THE PROXIMAL BODY COULD NOT BE REMOVED FROM THE DISTAL STEM, THEREFORE THE SURGEON DECIDED TO REMOVE THE ENTIRE STEM (PROXIMAL + DISTAL). THE REVISION SURGERY WAS ALSO TREATED WITH AN M-VIZION. HERE, THE SURGEON CHOSE A 16MM 180MM DISTAL STEM WITH A LONGER PROXIMAL BODY 20MM 70MM TO COMPENSATE FOR THE INSTABILITY.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 21708063 ↗