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M-Vizion Femoral Revision System 01.22.135Recalls & reported problems

Medacta International SA · Distal Stem Ø16mm L 180mm straight · Class 2 · Implant

All models of M-Vizion Femoral Revision System (30)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040728935), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Fracture1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 17, 2020Fracture; Appropriate Device Problem Term/Code Not Available

    AFTER THE PRIMARY HIP SURGERY, WHEN THE SURGEON WAS TAKING X-RAYS, IT WAS OBSERVED THAT THE DISTAL TIP OF THE STEM PENETRATED THE ANTERIOR CORTEX OF THE FEMUR. THE SURGEON OPERATED ON THE PATIENT AGAIN, AND CABLED AND PLATED THE FRACTURE. NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Bone Fracture(s)

    MAUDE report 10852288 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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