M-Vizion Femoral Revision System 01.22.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971263543), received between Jul 25, 2022 and Jul 25, 2022 — classified as 1 injury.

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.

• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. SUBSEQUENTLY, ON (B)(6) 2022, THE PATIENT CAME IN AND HAD THE COMPETITOR STEM REVISED TO A MEDACTA PROXIMAL BODY AND DISTAL STEM AND COMPETITOR HEAD REVISED TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND PROXIMAL BODY WITH A NEW MEDACTA HEAD AND PROXIMAL BODY. THE SURGEON ALSO REVISED THE COMPETITOR CUP AND LINER WITH A NEW COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 15092006 ↗