VISIONAIRERecalls & reported problems across all models

We found 25 models of VISIONAIRE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 222 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2017 and Jun 7, 2026 — classified as 145 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (70 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 VISIONAIRE problems

VISIONAIRE models

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

• VISIONAIRE V0100109

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  45 reports
• VISIONAIRE V0100112

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  43 reports
• VISIONAIRE V0200109

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  39 reports
• VISIONAIRE V0200112

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  29 reports
• VISIONAIRE V0100022

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  12 reports
• VISIONAIRE V0100023

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  12 reports
• VISIONAIRE V0100082

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• VISIONAIRE V0200023

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• VISIONAIRE V0100106

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  5 reports
• VISIONAIRE V0100107

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  4 reports
• VISIONAIRE V0200022

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VISIONAIRE V0200106

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  3 reports
• VISIONAIRE V0200013

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VISIONAIRE 71440302

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VISIONAIRE V0100108

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VISIONAIRE V0100012

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  2 reports
• VISIONAIRE V0100020

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0100030

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0100083

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0100080

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE 71440303

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0100110

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0200110

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0200111

  PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
  1 report
• VISIONAIRE V0200128

  Knee arthroplasty implantation system
  1 report

Recent VISIONAIRE adverse event reports

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

• MalfunctionJun 7, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE VISIONAIRE BLOCK OF ONE (1) NS VIS ADPT GUIDE LGNP KIT HAD A POOR FIT ONTO PATIENT'S FEMUR ON MEDIAL SIDE AND ANTERIOR HOOK REGION. THE POOR FIT OF THE BLOCK MEANT THE CUT WAS NOT IN THE POSITION IT SHOULD, AND THE SURGEON CUT TWO MORE MILLIMETERS OF BONE THAN HE INTENDED. THE FEMUR HAD TO BE RE-CUT, AND THE CASE TOOK LONGER THAN SCHEDULED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 25422601 ↗
• MalfunctionMar 30, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CUTS WERE MADE USING A VIS ADPT GUIDE LGNP KIT. ON THE TRIAL OF THE CRUCIATE RETAINING (CR) FEMORAL COMPONENT, IT APPEARED TO BE IN EXCESSIVE EXTERNAL ROTATION. IN EXTENSION, ALIGNMENT WAS FINE, BUT IN FLEXION IT OPENED MEDIALLY. IN ORDER TO ACHIEVE A BALANCED KNEE, THE POSTERIOR CRUCIATE LIGAMENT (PCL) HAD TO BE RESECTED, AND THE CR KNEE CONVERTED TO A POSTERIOR STABILIZED (PS) KNEE. AN ADDITIONAL BONE RESECTION WAS REQUIRED AS WELL. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24736966 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT LEGION CR VISIONAIRE SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT'S LEG REMAINED IN A VALGUS POSITION AFTER THE SURGERY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) GNS II CMT TIB SIZE 6 {} LEFT WAS EXPLANTED, AN AXIS- CORRECTION WAS PERFORMED AND A LEGION TIBIAL IMPLANT WITH LONGSTEM WAS IMPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24353442 ↗
• MalfunctionDec 30, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) NS VIS ADPT GUIDE JII KIT WAS RESECTING TOO MUCH POSTERIOR FEMUR, THE ISSUE WAS NOTICED ONLY AFTER RESECTIONS WERE MADE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A 15MM INSERT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23922592 ↗
• MalfunctionDec 8, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE FEMORAL BLOCK DID NOT FIT THE PATIENT'S BONE AND COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED, AFTER 15 MINUTES SURGICAL DELAY, WITH AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742080 ↗
• MalfunctionDec 3, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT IN A VIS ADPT GUIDE KIT JII, THE FEMUR COMPONENT TURNED OUT TO BE A SOLID SIZE 4 VIA THE SIZER, NO NOTCH; BUT THE TIBIA WAS A SIZE 5. THE ORIGINAL SIZES PLANNED FOR THE FEMORAL AND TIBIAL COMPONENTS WAS A SIZE 6. OTHER THAN THE SIZING, THE BLOCKS WERE A GOOD FIT. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705527 ↗
• InjuryDec 3, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKR, ONE (1) VIS ADPT GUIDE LGNP KIT DID NOT FIT THE FEMUR. IT WAS DECIDED AT THE TIME THAT IT CLOSE TO PROCEED. HOWEVER, THE DISTAL PINS FOR FEMORAL ROTATION FORCED FEMUR INTO EXTRA EXTERNAL ROTATION. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, AS THE SURGEON HAD TO PROCEED TO POSTERIOR STABILIZED TECHNIQUE INSTEAD OF CRUCIATE RETAINING. AS A RESULT, THE POSTERIOR CRUCIATE LIGAMENT WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23702834 ↗
• InjuryDec 2, 2025Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE A TKR PROCEDURE, WHEN LOOKING AT THE PLAN FOR VISIONAIRE, USING ONE (1) NS VIS ADPT GUIDE LGNP KIT, THE PLAN INDICATED GENESIS 2 AS THE IMPLANT WHEN IT WAS MEANT TO BE LEGION. AFTER DISCUSSION WITH THE ENGINEERS IT WAS AGREED THAT THE PLAN WAS FOR A LEGION BUT HAD BEEN INCORRECTLY NAMED AS A GENESIS 2. DURING THE TKR, WHILE INSPECTING THE FEMUR VISIONAIRE BLOCK ON THE NATIVE FEMUR, IT APPEARED TO SIT UP APPROXIMATELY 2 MM ON THE MEDIAL SIDE. PROCEEDING WITH THE SURGERY, USING THE VISIONAIRE BLOCK, THE POSTERIOR GAPS OF THE MEDIAL SIDE CUTS WERE MEASURED, AND IT WAS NOTICED THAT IT WERE OVER RESECTED BY 4MM FROM THE PLAN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, FROM CRUCIATE RETAINING TO POSTERIOR STABILIZED FOR BETTER STABILIZATION. THIS CHANGE REQUIRED MORE SURGICAL STEPS AND ADDITIONAL CUTTING OF THE FEMUR TO ACCOMMODATE A PS BOX. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23700165 ↗
• MalfunctionDec 2, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE DOCTOR TRIED TO PUT THE FEMORAL GUIDE OF ONE (1) VIS ADPT GUIDE KIT JII ON, THE MEDIAL PART OF THE GUIDE DID NOT SIT FLUSH TO THE BONE; IT WAS ROUGHLY 4-5MM AWAY FROM CONTACTING THE BONE, WHICH GAVE AN INACCURATE DISTAL CUT. THE SIZING OF THE FEMUR AND TIBIA WAS TOO BIG AS WELL, RESULTING IN DOWNSIZING OF BOTH THE FEMORAL AND TIBIAL COMPONENTS. IT WAS NECESSARY TO RECUT THE FEMUR TO CONTINUE THE CASE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE. THE PATIENT'S CURRENT HEALTH STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693305 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY USING A NS VIS ADPT GUIDE LGNP KIT, THE FEMUR NOTCHED. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED, HOW THE ISSUE WAS ADDRESSED OR IF THIS CAUSED A SURGICAL DELAY.

  Patient problems: Bone Notching

  MAUDE report 23450928 ↗
• MalfunctionSep 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE BLOCKS OF ONE (1) VIS ADPT GUIDE LGNP KIT DID NOT FIT APPROPRIATELY; CUTS WERE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE TO INSTRUMENTED TECHNIQUE AND USING A 15MM POLY INSTEAD OF 9-10MM. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 23163853 ↗
• MalfunctionAug 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON PLACED ONE (1) NS VIS ADPT GUIDE GII KIT, AND IT APPEARED TO FIT WELL. AFTER THE DISTAL FEMORAL CUT, THE MEDIAL DISTAL RESECTION SEEMED SMALLER THAN PLANNED. CUT APPROXIMATELY 4MM INSTEAD OF 7.5MM. HE THEN PLACED THE 4-1 BLOCK, AND THE MEDIAL POSTERIOR RESECTION WAS EXCESSIVE, LOOKING TO BE IN EXCESS OF 20MM. THE PROCEDURE WAS RESUMED, AFTER SIGNIFICANT DELAY, BY ADJUSTING MANUALLY THE CUTTING BLOCK TO TRY TO GET APPROPRIATE CUTS. AFTER TRIAL AND ERROR PLACING THE 4-1 BLOCK, THE SURGEON WAS ABLE TO GET IT IN POSITION SO AS NOT TO NOTCH ANTERIORLY AND GET EVEN CUTS POSTERIORLY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE, NO OVERCUTS WERE PERFORMED. PATIENT CURRENT HEALTH STATUS IS RECOVERING AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778906 ↗
• MalfunctionJun 9, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY, DRILL HOLES IN THE CUTTING GUIDES DID NOT ALIGN WITH THE JNS VIS ADPT GUIDE JII KIT; THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACK-UP DEVICE AND THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168128 ↗
• InjuryJun 6, 2025Positioning Failure; Inadequacy of Device Shape and/or Size; Positioning Failure; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY, USING A NS VIS ADPT GUIDE LGNP KIT, THE FEMUR BLOCK DID NOT FIT CORRECTLY OR FLUSH ONTO THE BONE ON THE PRE PLAN THE DISTAL CUTS WERE SUPPOSED TO BE 8.5MM (MEDIAL) AND 9.5MM (LATERAL) WHEN THE CUTS OF BONE WERE MEASURED IT WAS 7MM ON BOTH SIDES. ADDITIONALLY, THE TIBIAL BLOCK PADDLE DID NOT SIT ONTO THE PLATEAU, THE SURGEON MANIPULATED BY HAND USING THE DROP ROD WITH THE VISIONAIRE ALIGNMENT GUIDE AND HE THEN CUT EXTRA 2MM EXTRA ON THE TIBIA TO CORRECT THE PATIENTS FIXED FLEXION DEFORMITY. THERE WERE 2 MM EXTRA ON TIBIAL CUT, UNPLANNED CUTS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s); Perforation

  MAUDE report 22157551 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) VIS ALIGNMENT ROD WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101531 ↗

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