M-Vizion Femoral Revision System 01.22.005Recalls & reported problems
Medacta International SA · Proximal Body Ø20mm L 80mm STD · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971240834), received between May 17, 2021 and Aug 31, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Invagination” (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
- Material Invagination1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2021Appropriate Device Problem Term/Code Not Available
2 MONTHS AFTER THE PREVIOUS SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE PROXIMAL BODY AND HEAD, PERFORMED A WASHOUT, AND REPLACED THE PROXIMAL BODY AND HEAD WITH NEW COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT HAD PROXIMAL BODY AND HEAD REVISION DUE TO STEM SUBSIDENCE.
Patient problems: Unspecified Infection
MAUDE report 12390512 ↗InjuryMay 17, 2021Material Invagination
REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY DUE TO SUBSIDENCE OF PROXIMAL AND DISTAL PART OF THE STEM. THE SURGEON SUCCESSFULLY REVISED THE PROXIMAL BODY, DISTAL STEM, OPTION HEAD, AND OPTION SLEEVE WITH COMPETITOR COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 11831978 ↗
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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