M-Vizion Femoral Revision System 01.22.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030884993), received between Oct 1, 2021 and Jun 26, 2025 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING A REVISION SURGERY THE M-VIZION DISTAL STEM GOT STUCK IN THE FEMORAL CANAL AND COULD NOT BE COMPLETELY INSERTED. SURGEON TRIED TO REMOVE THE STEM BUT ATTEMPTS WERE NOT SUCCESSFUL. PLANNED SIZE WERE REPORTED TO BE Ø13MM L 140MM DISTAL STEM AND Ø20MM L 40MM PROXIMAL BODY. REAMING WAS COMPLETED USING SIZE 13 REAMER AND TRAILING STEPS HAVE BEEN REPORTED SUCCESSFUL CONCLUDING WITH THE Ø13MM L 140MM TRIAL. FINAL IMPLANTS WERE ASSEMBLED IN THE BACKTABLE. AT TOTAL OF 30 MINUTES DELAY WERE REPORTED DUE TO THE ATTEMPTS TO REMOVE THE STEM AND DIFFICULT FINAL REDUCTION. SURGEON LEFT THE STEM IN PLACE AND CLOSED THE PATIENT RESULTING IN A LEG LENGTHENING OF ABOUT 1 CENTIMETER.

  Patient problems: Unequal Limb Length

  MAUDE report 22337283 ↗
• InjuryMay 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT TWO WEEKS, 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 22078242 ↗
• InjuryNov 19, 2024Migration; Migration

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING WHICH CAUSED A PERIPROSTHETIC FRACTURE. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON THINKS THAT THE STEM WAS UNDERSIZED FOR THE PATIENT.

  Patient problems: Implant Pain

  MAUDE report 20724173 ↗
• InjuryJul 25, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY. METAL CERCLAGE CAME INTO CONTACT WITH THE STEM CAUSING ABRASION. CERCAGLE WAS USED TO FIX A FEMORAL FRACTURE THAT OCCURRED WITH COMPETITOR COMPONENTS (THE PATIENT HAD A PRIMARY SURGERY WITH COMPETITOR'S COMPONENTS).

  Patient problems: Inadequate Osseointegration

  MAUDE report 19826342 ↗
• InjuryOct 1, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12560085 ↗