M-Vizion Femoral Revision SystemRecalls & reported problems across all models

We found 30 models of M-Vizion Femoral Revision System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2020 and Jul 2, 2026 — classified as 43 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported M-Vizion Femoral Revision System problems

M-Vizion Femoral Revision System models

30 models, most reported first. Each model has its own page with its reports, recalls and device details.

• M-Vizion Femoral Revision System 01.22.102

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  5 reports
• M-Vizion Femoral Revision System 01.22.103

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• M-Vizion Femoral Revision System 01.22.104

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• M-Vizion Femoral Revision System 01.22.134

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• M-Vizion Femoral Revision System 01.22.408

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• M-Vizion Femoral Revision System 01.22.427

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  3 reports
• M-Vizion Femoral Revision System 01.22.201

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  2 reports
• M-Vizion Femoral Revision System 01.22.132

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  2 reports
• M-Vizion Femoral Revision System 01.22.005

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  2 reports
• M-Vizion Femoral Revision System 01.22.403

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  2 reports
• M-Vizion Femoral Revision System 01.22.008

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.010

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.105

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.106

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.009

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.131

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.133

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.135

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.165

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.168

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.643

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.705

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.004

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.006

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.402

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.405

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.409

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.410

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.411

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• M-Vizion Femoral Revision System 01.22.448

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report

Recent M-Vizion Femoral Revision System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25691665 ↗
• MalfunctionMay 28, 2026Material Deformation; Mechanical Jam

  DURING A REVISION SURGERY PERFORMED ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, IT WAS NOT POSSIBLE TO SEPARATE THE PROXIMAL BODY FROM THE DISTAL STEM. INSTRUMENTS FOR REMOVAL DEFORMED DURING THE ATTEMPTS. AS THE ORIENTATION OF THE PROXIMAL BODY COULD NOT BE CHANGED, THE SURGEON DECIDED TO REVISE THE COMPETITOR`S CUP TO ADDRESS THE RISK OF JOINT LUXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313931 ↗
• MalfunctionMay 28, 2026Migration or Expulsion of Device

  PRIMARY SURGERY PERFORMED ON (B)(6) 2025. REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO JOINT LUXATION INVOLVING COMPETITOR` COMPONENTS (HEAD, LINER AND CUP FROM COMPETITOR). DURING THE REVISION, THE LOCKING SCREW WAS FOUND LOOSE. THE SAME LOCKING SCREW WASRETIGHTENED. IN ADDITION, AS THE PROXIMAL BODY COULD NOT BE SEPARATED FROM THE DISTAL STEM, THE SURGEON DECIDED TO REVISE THE ACETABUL COMPETITOR`S COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313929 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 15 DAYS FROM PRIMARY DUE TO LEG LENGTH DISCREPANCY.THE SURGEON REVISED THE PROXIMAL BODY, THE LINER, AND THE STEM TO ADDRESS THE DISCREPANCY.

  Patient problems: Unequal Limb Length

  MAUDE report 25268615 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY AND REVISION SURGERY ON THE SAME DAY. DURING THE PRIMARY PROCEDURE, THE SURGEON NOTED THAT THE BONE AND CEMENT APPEARED TO PUSH THE IMPLANT IN AN ANTEROLATERAL DIRECTION, THOUGH IT INITIALLY SEEMED ACCEPTABLE. AFTER SURGERY, WHILE THE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT, A POSTOPERATIVE X-RAY SHOWED THAT THE STEM HAD PERFORATED THE BONE. POOR BONE QUALITY WAS ALSO OBSERVED. ALL COMPONENTS REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24558194 ↗
• 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 ↗
• MalfunctionFeb 24, 2026Mechanical Jam

  DURING THE ATTEMPTS OF REMOVAL OF THE PROXIMAL BODY FROM THE DISTAL STEM, THE PROXIMAL BODY HANDLE DEFORMED AND IT WAS NOT POSSIBLE TO DISCONNECT THE PROXIMAL BODY FROM THE DISTAL STEM. THE SURGEON LEFT THE CONSTRUCT IN PLACE WITH NO LOCKING SCREW AND PROCEEDED CHANGING ONLY THE HEAD. THIS EVENT HAPPENED DURING A REVISION SURGERY PERFORMED ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO INSTABILITY AND DISLOCATION. THE SURGEON WANTED TO CORRECT THE ROTATION OF THE PROXIMAL BODY AND TO IMPLANT A PROXIMAL BODY 10MM LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429841 ↗
• InjuryNov 5, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23477198 ↗
• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 MONTHS FROM THE PRIMARY THE SURGEON PERFORMED A WASH OUT, AND REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC HIP SPACER. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23063081 ↗
• InjuryJul 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 10 MONTHS FROM PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22674986 ↗
• InjuryJul 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6)2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR CUP AND LINER AND MEDACTA PROXIMAL BODY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22674985 ↗
• InjuryJul 29, 2025Positioning Problem; Positioning Problem

  AT ABOUT 1 WEEK FROM PRIMARY THE PATIENT UNDERWENT REVISION SURGERY DUE TO A MALPOSITIONING OF THE DISTAL STEM (FALSA VIA). THE ENTIRE CONSTRUCT HAS BEEN REVISED. THE TWO PARTS COULD NOT BE SEPARATED AS THE TIP OF THE SCREWDRIVER USING DURING PRIMARY BROKE INSIDE THE LOCKING SCREW. DURING THE TIGHTENING OF THE LOCKING SCREW THE SCREW DRIVER TIP BROKE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22643026 ↗
• MalfunctionJun 26, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING A REVISION SURGERY THE M-VIZION DISTAL STEM GOT STUCK IN THE FEMORAL CANAL AND COULD NOT BE COMPLETELY INSERTED. SURGEON TRIED TO REMOVE THE STEM BUT ATTEMPTS WERE NOT SUCCESSFUL. PLANNED SIZE WERE REPORTED TO BE Ø13MM L 140MM DISTAL STEM AND Ø20MM L 40MM PROXIMAL BODY. REAMING WAS COMPLETED USING SIZE 13 REAMER AND TRAILING STEPS HAVE BEEN REPORTED SUCCESSFUL CONCLUDING WITH THE Ø13MM L 140MM TRIAL. FINAL IMPLANTS WERE ASSEMBLED IN THE BACKTABLE. AT TOTAL OF 30 MINUTES DELAY WERE REPORTED DUE TO THE ATTEMPTS TO REMOVE THE STEM AND DIFFICULT FINAL REDUCTION. SURGEON LEFT THE STEM IN PLACE AND CLOSED THE PATIENT RESULTING IN A LEG LENGTHENING OF ABOUT 1 CENTIMETER.

  Patient problems: Unequal Limb Length

  MAUDE report 22337283 ↗
• InjuryJun 10, 2025Migration; Migration

  ABOUT 5 MONTHS AFTER THE FIRST REVISION SURGERY, ANOTHER REVISION SURGERY WAS PERFORMED DUE TO SECONDARY MOVEMENT AND SUBSIDENCE. THE PATIENT HAS A FIRST REVISION SURGERY (ON (B)(6) 2025) DUE TO A PERIPROSTHETIC FEMORAL FRACTURE CAUSED BY A FALL (PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2013). PSEUDOARTHROSIS OF THE FRACTURE BORDERS IS CURRENTLY PRESENT, ESPECIALLY AROUND THE GREATER TROCHANTER AND ISTMUS REGION OF THE FEMUR. M-VIZION STEM REMOVED WITHOUT FURTHER DIFFICULTIES AND REPLACED WITH COMPETITOR REVISION SHAFT (CORAIL REVISION), PARTIAL REOPENING OF FRACTURE AREA, NEW CERCLAGES, AND PROXIMAL FEMORAL PLATE PLACED TO STABILIZE THE FRACTURE AROUND THE ISTHMUS AND GREATER TROCHANTER. VERSAFIT DM CUP IS STABLE AND HAS GOOD PLACEMENT IN THE ACETABULUM, SO IT WAS LEFT IN SITU. LINER AND HEAD REPLACED WITH THE SAME SIZES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22175023 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. IT WAS NOTED THAT THE PROXIMAL BODY WAS RETROVERTED AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY ALL COMPONENTS WERE EXTRACTED INCLUDING THE NON-MEDACTA CUP/LINER. THE CASE WAS THEN CARRIED OUT WITH SUCCESS WITH A NEW M-VIZION STEM AND PROXIMAL BODY ALONG WITH A MEDACTA BIPOLAR HEAD CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22114094 ↗

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