M-Vizion Femoral Revision System 01.22.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040728904), received between Dec 10, 2020 and Sep 16, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 MONTHS FROM THE PRIMARY THE SURGEON PERFORMED A WASH OUT, AND REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC HIP SPACER. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23063081 ↗
• InjuryDec 10, 2020Material Protrusion/Extrusion

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. AFTER THE SURGERY(THE SAME DAY), THE SURGEON CHECKED AND DISCOVERED THE TIP OF THE FEMORAL STEM PROTRUDED FROM THE MEDULLARY CAVITY AT X-RAY. THE BONE FRACTURE OCCURRED DURING THE PRIMARY SURGERY. THE SURGEON REPLACED THE STEM WITH NEW ONE. THE ANTERIOR CURVATURE WAS TAKEN IN ACCOUNT DURING THE PLANNING. THE TRIAL PHASE WAS PERFORMED BUT THE X-RAY WAS NOT TAKEN IN THIS PHASE. THE SURGEON USED POSTERIOR APPROACH AND DONE REAMING MANUALLY (13 MM SIZE). THE SIZE OF THE USED COMPONENTS WAS THE SAME AS DURING PLANNING AND NO DEVIATION FROM THE SURGERY TECHNIQUE WAS DONE. THE BONE OF THE PATIENT WAS WEAK, PREVIOUSLY THIS PATIENT HAD A REVISION DUE TO INFECTION(COMPETITOR IMPLANTS), AND THIS IMPLANTS WERE REPLACED WITH CEMENT MOLD.

  Patient problems: Bone Fracture(s)

  MAUDE report 10983317 ↗