M-Vizion Femoral Revision System 01.22.201Recalls & reported problems
Medacta International SA · Locking Screw · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030885143), received between Oct 4, 2024 and Mar 3, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Break
THE LOCKING SCREW WAS FOUND TO BE FRACTURED DURING THE REVISION SURGERY, MAKING REMOVAL OF THE PROXIMAL BODY FROM THE DISTAL BODY IMPOSSIBLE. AN ATTEMPT TO EXPLANT THE ENTIRE STEM WAS UNSUCCESSFUL. CONSEQUENTLY, THE SURGEON DECIDED TO LEAVE THE STEM IN SITU AND REPLACE ONLY THE FEMORAL HEAD WITH A COMPETITOR COMPONENT. THE SURGERY WAS PROLONGED BY ABOUT 30 MINUTES. IT IS SUSPECTED THAT THE LOCKING SCREW BROKE WHEN IMPLANTED DURING THE PRIMARY PROCEDURE. THE REVISION SURGERY WAS PERFORMED ABOUT 4 YEARS AFTER THE PRIMARY SURGERY DUE TO PAIN AND MALROTATION OF THE STEM. THE SURGEON WANTED TO REVISE THE M-VIZION PROXIMAL BODY TO CORRECT THE IMPLANT ANGLE.
Patient problems: Implant Pain
MAUDE report 24494911 ↗MalfunctionOct 4, 2024Break; Break
DIFFERENT TRIAL PROXIMAL BODIES COULD NOT BE COUPLED WITH THE FINAL DISTAL STEM IMPLANT. AFTER MANY ATTEMPTS, THE LOCKING SCREW (IMPLANT) WAS USED TO FIX THE TRIAL PROXIMAL BODY WITH THE FINAL DISTAL IMPLANT. THE SCREW HEAD BROKE WHILE TIGHTENING WITH THE TORQUE WRENCH. THE SURGEON REMOVED THE WHOLE IMPLANT AND TOOK AN ALTERNATIVE (PRE-ASSEMBLED IN BACK-TABLE) TO COMPLETE THE SURGERY. 1H OF DELAY DUE TO THIS EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20369575 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
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- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
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- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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