M-Vizion Femoral Revision System 01.22.134Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040728928), received between Sep 12, 2023 and May 30, 2025 — classified as 3 injuries.

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.

• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. IT WAS NOTED THAT THE PROXIMAL BODY WAS RETROVERTED AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY ALL COMPONENTS WERE EXTRACTED INCLUDING THE NON-MEDACTA CUP/LINER. THE CASE WAS THEN CARRIED OUT WITH SUCCESS WITH A NEW M-VIZION STEM AND PROXIMAL BODY ALONG WITH A MEDACTA BIPOLAR HEAD CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22114094 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE REVISION SURGERY DUE TO PAIN, PERFORMED ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, IT WAS NOTED THAT THE PROXIMAL BODY WAS RETROVERTED. THE PROXIMAL BODY WOULD NOT DISENGAGE FROM THE STEM. AN ATTEMPT AND MANUAL DISENGAGEMENT RESULTED IN THE ENTIRE CONSTRUCT EXTRACTION. THE CONSTRUCT WAS THEN REINSERTED WITH THE PROPER VERSION. REDUCTION WAS DIFFICULT AND RESULTED IN A NEW DISTAL FEMUR FRACTURE. ALL COMPONENTS WERE EXTRACTED INCLUDING THE NON-MEDACTA CUP/LINER. THE CASE WAS THEN CARRIED OUT WITH SUCCESS WITH A NEW M-VIZION STEM AND PROXIMAL BODY ALONG WITH A MEDACTA BIPOLAR HEAD CONSTRUCT. FRACTURE FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 22043492 ↗
• InjurySep 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DURING THE PRIMARY HIP SURGERY AND DURING FINAL TORQUEING OF THE M-VIZION LOCKING SCREW, THE FEMUR FRACTURED DISTALLY. THE SURGEON WAS USING ANTIROTATIONAL HANDLE 01.22.10.0154. PLATE, SCREWS AND CABLES WERE PLACED TO FIX THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. POOR PATIENT'S BONE QUALITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17727779 ↗