VISIONAIRE V0200109Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00885556656563), received between Mar 6, 2019 and Jun 7, 2026 — classified as 34 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 28, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE VISIONAIRE CUT GUIDE CUT MORE TIBIA THAN IT SHOULD HAVE. THE SURGERY WAS COMPLETED WITH A S+N BACK-UP DEVICE WITHOUT DELAY. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 20805817 ↗
• InjuryNov 22, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA, THE SURGEON FELT LIKE THE FEMORAL GUIDE NS VIS ADPT GUIDE LGNP KIT WAS WRONG FROM THE START AND QUESTIONED IF IT WAS THE CORRECT BLOCK AND IF SEATED COMPLETELY. AFTER RECONFIRMING, WAS PROCEEDED, AND THE SURGEON AGAIN FELT THE BLOCK DID NOT PROVIDE WITH AN ACCURATE DISTAL CUT. THE SURGEON MOVED FORWARD WITH REST OF THE CASE AND AT THE END WE TRIALED AND HE DROPPED A LONG ROD TO CHECK ALIGNMENT AND FELT HIS FEMUR WAS CUT IN VARUS. AT THE END, A CONVENTIONAL IM ALIGNMENT GUIDES WERE USED TO RECUT THE DISTAL FEMUR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 20757382 ↗
• InjurySep 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT HAD TO RECUT WITH THE NS VIS ADPT GUIDE LGNP KIT TO PUT MORE EXTERNAL ROTATION INTO THE FEMORAL COMPONENT. IT CUT THROUGH BOTH VISIONAIRE BLOCKS FOR THE DISTAL FEMUR AND PROXIMAL TIBIA CUT, PROCEEDED AS NORMAL WITH HIS 4IN1 FEMORAL CUT BLOCK USING THE PILOT HOLES FROM THE VISIONAIRE GUIDE. AFTER TRIALING THE COMPONENT, IT NEEDED TO BE MORE FEMORAL ROTATION IN THE COMPONENT. AT THIS POINT HE PUT THE 4 IN 1 CUT BLOCK BACK ONTO THE FEMUR, EXCEPT HE SHIFTED THE MEDIAL PIN HOLE SLIGHTLY ANTERIOR AND THEN RECUT. THIS WAS ABLE TO RESOLVE THE FEMORAL ROTATION PROBLEM INTRA-OPERATIVELY. THE PROCEDURE WAS RESUMED, USING THE SAME DEVICE. IT IS UNKNOWN IF A DELAY WAS PRESENTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17774166 ↗
• InjuryJun 11, 2023Positioning Failure; Inadequacy of Device Shape and/or Size; Positioning Failure; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA SURGERY, ONE (X1) VIS ADPT GUIDE LGNP KIT DID NOT FIT CORRECTLY. THE DROP ROD WAS USED, AND IT LOOKED LIKE THE TIBIA WOULD BE CUT INTO EXTREME VARUS. THE TIBIA BLOCK WAS NOT USED AND THEY ENDED UP CONVERTING TO STANDARD INSTRUMENTATION ON THE TIBIA. THEY ENDED UP AT A MUCH LARGER POLY THICKNESS THAN WHAT THE VISIONAIRE PLAN HAD PROVIDED THEM TO SHOOT FOR. THE PROCEDURE WAS COMPLETED BY CHANGE IN SURGICAL TECHNIQUE, AFTER A NON-SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102356 ↗
• InjuryApr 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, WHILE UTILIZING AN NS VIS ADPT GUIDE LGNP KIT, AN 15MM INSERT WAS USED AS A CONSEQUENCE OF EXCESSIVE TIBIA RESECTION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 16791797 ↗
• InjuryApr 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, WHILE UTILIZING AN NS VIS ADPT GUIDE LGNP KIT, AN 15MM INSERT WAS USED AS A CONSEQUENCE OF EXCESSIVE TIBIA RESECTION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 16791779 ↗
• InjuryApr 18, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, WHILE UTILIZING AN NS VIS ADPT GUIDE LGNP KIT, AN 15MM INSERT WAS USED AS A CONSEQUENCE OF EXCESSIVE TIBIA RESECTION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 16765356 ↗
• MalfunctionApr 14, 2023Inadequacy of Device Shape and/or Size; Mechanics Altered; Inadequacy of Device Shape and/or Size; Mechanics Altered

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIBIA CUTTING BLOCK OF A VIS ADPT GUIDE LGNP KIT WAS OFF, AFTER CUT THE KNEE WAS VERY TIGHT IN FLEXION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746941 ↗
• InjuryFeb 13, 2023Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE DISTAL FEMORAL CUT HAD TO BE ADJUSTED WITH AN ADDITIONAL 8MM DISTAL CUT FROM THE ORIGINAL PLAN. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368890 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKR, USING A NS VIS ADPT GUIDE LGNP KIT, THE POST-OPERATIVE X-RAY CONFIRM THE TIBIAL CUT AND IMPLANT PLACEMENT HIGHLY VARUS. THE SURGEON STATED THAT INTRA-OPERATIVE THE VISIONAIRE VAG BLOCKS SEEM TO FIT WELL AND THE BALANCING ON BOTH KNEES SEEM TO BE FINE. IT IS UNKNOWN THE CAUSE OF THIS OUTCOME FOR THE PATIENT. IT IS UNKNOWN IF AN ADDITIONAL PROCEDURE/INTERVENTION IS REQUIRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement; Unequal Limb Length

  MAUDE report 15839953 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKR, USING A NS VIS ADPT GUIDE LGNP KIT, THE POST-OPERATIVE X-RAY CONFIRM THE TIBIAL CUT AND IMPLANT PLACEMENT HIGHLY VARUS DUE TO INADEQUATE RESECTION OF LATERAL TIBIA PLATEAU. THE SURGEON STATED THAT INTRA-OPERATIVE THE VISIONAIRE VAG BLOCKS SEEM TO FIT WELL AND THE BALANCING ON BOTH KNEES SEEM TO BE FINE. IT IS UNKNOWN THE CAUSE OF THIS OUTCOME FOR THE PATIENT. CONCERN IS REGARDING PAIN/IMPLANT LONGEVITY AS NOT IN MECHANICAL ALIGNMENT WITH HIP KNEE AXIS. IT IS UNKNOWN IF AN ADDITIONAL PROCEDURE/INTERVENTION IS REQUIRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unequal Limb Length

  MAUDE report 15837921 ↗
• InjuryNov 10, 2022Nonstandard Device; Positioning Problem; Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT, DURING A TKA, USING AN NS VIS ADPT GUIDE LGNP KIT FOR LEGION PRIMARY CR TKA SURGERY CAUSED NOTCHING DURING THE ANTERIOR RESECTION DUE TO ENGINEER¿S ALIGNMENT.THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS REPORTED. PATIENT IS HEALTHY AND RECOVERING NORMALLY FROM SURGERY.

  Patient problems: Laceration(s)

  MAUDE report 15770676 ↗
• InjuryOct 4, 2022Nonstandard Device; Inadequacy of Device Shape and/or Size; Nonstandard Device; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, USING AN UNKN VISIONAIRE CUT GUIDE INSTR FOR LEGION PRIMARY CR TKA SURGERY CAUSED NOTCHING DURING THE ANTERIOR RESECTION DUE TO ENGINEER¿S ALIGNMENT. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS REPORTED. PATIENT IS HEALTHY AND RECOVERING NORMALLY FROM SURGERY.

  Patient problems: Laceration(s); Unspecified Tissue Injury

  MAUDE report 15535509 ↗
• InjuryOct 4, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, USING AN UNKN VISIONAIRE CUT GUIDE INSTR FOR LEGION PRIMARY CR TKA SURGERY CAUSED NOTCHING DURING THE ANTERIOR RESECTION DUE TO THE ENGINEER¿S ALIGNMENT. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED. PATIENT IS HEALTHY AND RECOVERING NORMALLY FROM SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15535490 ↗
• InjuryMay 7, 2022Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, IT WAS NOTICED THAT WHEN THE SURGEON PLACED THE NS VIS ADPT GUIDE LGNP TIB ON, THE ALIGNMENT DROP ROD WAS FALLING LATERALLY, THE SLOPE APPEARED OFF FROM WHAT WAS PLANNED AND THE ANTERIOR LATERAL PORTION OF THE TIBIA PADDLE WAS NOT FLUSH. THE SURGEON REMOVED THE BLOCK AND TRANSITIONED TO STANDARD INSTRUMENTATION. HIS RESECTIONS MEASURED 7MM LATERAL, 2.5-3.5MM MEDIAL. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316602 ↗
• InjuryMar 1, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMUR AND TIBIA GUIDES FROM A NS VIS ADPT GUIDE LGNP KIT WERE AIRBALLED WHEN FITTING BLOCKS. THE SURGEON HAD TO RECUT BOTH DISTAL FEMUR AND PROXIMAL TIBIA. AN ADDITIONAL 2MM WERE RESECTED ON THE FEMUR AND AN ADDITIONAL 4MM ON THE TIBIA. SURGERY WAS RESUMED, WITH A CHANGE IN SURGICAL TECHNIQUE. IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636326 ↗
• InjuryJan 25, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CUTTING SLOTS OF A NON STERILE VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY WERE NOT FULLY OPEN, A BLADE COULDN¿T PASS THROUGH THEM, ON BOTH FEMUR AND TIBIA CUTTING BLOCKS, IT WAS NEEDED TO SLIDE THE METAL BLOCKS OVER THE PINS TO MAKE THE CUTS. ALSO, THE FEMUR CUTTING BLOCK DID NOT CONTACT BONE DISTAL LATERAL AND ANTERIOR LATERAL, SO THE SURGEON HAD TO RECUT USING MECHANICAL INSTRUMENTS. ADDED, THE TIBIAL CUTTING BLOCK HAD GREAT CONTACT BUT CUT THE TIBIA IN ABOUT 2 DEGREES OF VALGUS., SO MANUAL INSTRUMENTS HAD TO BE USED TO CORRECT THIS ISSUE. SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM, EVEN THOUGH, THE SURGEON STATED THAT THIS MAY BE POTENTIALLY AFFECTING THE LONG TERM OUTCOME OF THIS PATIENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13353113 ↗
• InjuryJan 3, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A CUTTING BLOCK FROM A VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY DID NOT FIT PERFECTLY. IT WAS POORLY SUPPORTED IN THE ANTERO-INTERNAL AREA, OR IF THIS ONE WAS WELL SUPPORTED, THE BLOCK DID NOT FIT DISTALLY TO THE CONDYLES. THE BEST POSSIBLE FIT RESULTED IN PIN PLACEMENT WITH TOO MUCH EXTERNAL ROTATION. AFTER THE DISTAL CUT WAS PERFORMED, IT WAS IMMEDIATELY OBVIOUS THAT SOMETHING WAS WRONG. IT IS UNKNOWN IF THIS ISSUE CAUSED ANY SURGICAL DELAY; HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142410 ↗
• InjuryDec 17, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A RIGHT TKA SURGERY WITH A PATIENT THAT REQUIRES BI-LATERAL IMPLANTATIONS, A RIGHT NS VIS ADPT GUIDE LGNP KIT CAME WITH A LEFT FEMORAL GUIDE. THE SURGEON USED THE SAMPLE VISIONAIRE GUIDES PROVIDED FOR THE CASE IN ORDER TO CONTINUE THE PROCEDURE; HOWEVER, THE SAMPLE GUIDES ARE NOT INTENDED FOR USE DURING SURGERY SINCE THEY ARE SOLD AS NON-STERILE DEVICES. A NON-SIGNIFICANT DELAY OCCURRED AS A CONSEQUENCE OF THIS INCIDENT. ANY NEGATIVE IMPACT ON PATIENT HAS BEEN REPORTED SO FAR. IN ADDITION, THE SOUTH (B)(4) WAREHOUSE STAFF OPENED THE LEFT NS VIS ADPT GUIDE LGNP KIT AND CONFIRMED THAT IT INCLUDES THE RIGHT FEMORAL GUIDE. THE TKA FOR THE LEFT KNEE IS SCHEDULED FOR (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026301 ↗
• MalfunctionJun 24, 2021Inadequacy of Device Shape and/or Size; Fitting Problem; Inadequacy of Device Shape and/or Size; Fitting Problem

  IT WAS REPORTED, THAT DURING A TKA SURGERY, A NS VIS ADPT GUIDE LGNP KIT DID NOT WORK PROPERLY; THE TIBIA FIT WAS INSUFFICIENT. SURGERY WAS COMPLETED, WITHOUT SIGNIFICANT DELAY, BY USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063595 ↗
• MalfunctionJun 14, 2021Break; Delivered as Unsterile Product; Break; Delivered as Unsterile Product

  IT WAS REPORTED, THAT DURING SET UP, PRIOR TO TKA SURGERY, IT WAS NOTICED THAT THE NS VISIONAIRE CUT GUIDE LEGION FEM ARRIVED NON-STERILE WITH BOTH EXTENSION TABS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991780 ↗