M-Vizion Femoral Revision System 01.22.165Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040729116), received between Nov 20, 2024 and Nov 20, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  THE PATIENT HAD A PRIMARY SURGERY WITH A COMPETITOR ON AN UNKNOWN DATE. SUBSEQUENTLY, ON THE (B)(6) 2024, THE COMPETITOR STEM AND HEAD WERE REVISED TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR IMPLANTS. SURGERY WAS COMPLETED SUCCESSFULLY. NO ISSUES DETECTED WITH IMPLANTS, ONLY PAIN WAS REPORTED. IT IS UNKNOWN WHETHER OR NOT THE COMPETITOR LINER WAS REVISED, BUT A MEDACTA LINER WAS NOT USED IN ANY SURGERY. THE DISTRICT SALES MANAGER DIDN'T HAVE ANY REPS IN THIS HOSPITAL AREA SO NO OTHER INFORMATION IS AVAILABLE. FROM THE ANALYSIS OF THE X-RAYS, IT IS VISIBLE THAT JOINT LUXATION OCCURRED. MOREOVER, THE FEMUR SHAPE APPEARS IRREGULAR, WITH CERCLAGE WIRES AND THE STEM LIKELY SHOWS SIGNS OF SUBSIDENCE, PROBABLY A RESULT OF NON-ADEQUATE PRIMARY STABILITY.

  Patient problems: Implant Pain

  MAUDE report 20734636 ↗