M-Vizion Femoral Revision System 01.22.411Recalls & reported problems
Medacta International SA · Proximal Body Ø20mm L 80mm LAT with holes · 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 07630971263604), received between Apr 13, 2023 and Apr 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2023Malposition of Device; Malposition of Device
THE PATIENT HAD COMPETITOR COMPONENTS AND CAME IN ON (B)(6) 2023 FOR REASONS UNKNOWN AND THE SURGEON REVISED THE COMPETITOR CUP AND LINER WITH A MEDACTA CUP AND LINER, WITH THE INTENTION OF REVISING THE STEM AND HEAD A WEEK LATER. ON (B)(6) 2023, THE PATIENT CAME BACK IN AND HAD THE COMPETITOR STEM AND HEAD REVISED WITH A MEDACTA STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON DETERMINED THAT THE PATIENT'S STEM NEEDED MORE REVISION. THE SURGEON PUT MORE ANTEVERSION IN STEM AND CHANGED THE LINER TO AN OFFSET LINER FOR MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS AT RISK OF DISLOCATION AND HAD PREVIOUS SPINE SURGERY.
Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions
MAUDE report 16732296 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- 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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