VISIONAIRE V0100112Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00885556656419), received between Apr 13, 2018 and Dec 8, 2025 — classified as 34 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryFeb 4, 2025Inadequacy 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 TIBIAL CUT WITH THE VIS ADPT GUIDE KIT JII WAS ACTUALLY IN 2-3 DEGREE¿S OF VARUS AS WELL AND HAD TO RECUT INTO SOME VALGUS. THE DISTAL THIRD OF STITCHING MAY HAVE BEEN INTERNALLY ROTATED AS THE PATIENT HAS A SLIGHT VARUS BOW TO HIS TIBIA. THIS PLAN WAS LACKING ATTENTION TO DETAIL. POSTERIOR CUTS WERE TOO BIG, THIS HAS BEEN A CONSISTENT PROBLEM. THE POSTERIOR CONDYLE CUTS HAVE CONSISTENTLY BEEN 2MM THICKER THAN PLAN WHEN SURGEON CALIPER THEM. DISTAL AND TIBIAL RESECTIONS HAVE BEEN GOOD BUT SALES REP THINK THAT THE BLOCKS HAVE BEEN POSITIONED TOO FAR ANTERIOR. THE SURGERY WAS COMPLETED MOSTLY WITH VISIONAIRE BLOCKS, RECUT THE TIBIA WITH THE STANDARD CUT BLOCKS IN UNIV BASE TRAY, AFTER A NON-SIGNIFICANT DELAY. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

  Patient problems: Laceration(s)

  MAUDE report 21301646 ↗
• InjuryAug 5, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE CUTS MADE USING ONE (1) VIS ADPT GUIDE KIT JII REMOVED TOO MUCH BONE FROM THE DISTAL FEMUR AND PROXIMAL TIBIA. WHILE THE INITIAL PLAN WAS TO USE AN 11 MM POLY INSERT, THE KNEE WAS EXTREMELY LOOSE AFTER THE CUTS AND DURING TRIALING. DUE TO THIS ISSUE, THE PATIENT NEEDED A 21 MM INSERT, AND EVEN WITH THIS LARGER SIZE, THE KNEE REMAINED HYPEREXTENDED IN EXTENSION. GIVEN THAT THE ALIGNMENT WAS PREPARED FOR AN 11 MM INSERT, THE PROCEDURE WAS DELAYED BY 30-40 MINUTES WHILE WAITING FOR THE PROPER INSTRUMENTS AND EQUIPMENT TO COMPLETE THE SURGERY. IT WAS MENTIONED THAT THIS PATIENT WILL MOST LIKELY NEED A REVISION. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 19906541 ↗
• InjuryAug 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING TKA SURGERY, WITH A VISIONAIRE ADAPTIVE GUIDE KIT JOURNEY II IN WHICH AN ALIGNMENT FOR A 11MM POLY WAS PLANNED, IT WAS NOTED THAT THE PATIENT WAS STILL HYPER WITH SUCH A LARGE POLY, AND THE KNEE WAS EXTREMELY LOOSE AFTER CUTS AND DURING TRIALING. DUE TO THIS, THE SURGEON NEEDED TO USE A 21 MM POLY. THE ALIGNMENT WAS PLANNED FOR A 11MM POLY, DID NOT PREPARE IT TO PUT IN A 21MM POLY. THE PROCEDURE WAS RESUMED, AFTER A DELAY OF ABOUT 30 MIN, WAITING FOR THE PROPER S+N INSTRUMENTS AND EQUIPMENT TO COMPLETE THE SURGERY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19889216 ↗
• MalfunctionFeb 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE VIS ADPT GUIDE KIT JII PRESENTED AN UNKNOWN PROBLEM. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY AND MULTIPLE TIBIAL RECUTS. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637603 ↗
• MalfunctionJan 24, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING TKA SURGERY, UTILIZING ONE (1) VIS ADPT GUIDE KIT JII, THE VISIONAIRE PLAN WAS SIZED FOR A 1 FEMUR AND 2 TIBIA. DOCTOR IMPLANTED A 4 FEMUR. WHICH IS 3 SIZES BIGGER THAN THE PLANNED SIZE. HE WANTS TO KNOW WHY THIS SIZING WAS SO OFF, AND HOW IT WILL BE PREVENTED IN THE FUTURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 18576234 ↗
• InjurySep 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A VISIONAIRE CASE, WHEN USING A VIS ADPT GUIDE KIT JII, THE IMPLANT CONDITIONS WERE TOO TIGHT. THEY DID NOT EXACTLY MATCH THE PATIENT'S BONE; THE PLANNED FEMUR WIDTH WAS TOO LARGE IT WAS AT THE LIMIT OF THE ACCEPTABLE SIZE. THE SPACER DID NOT FIT INTO THE FEMO-TIBIAL INTERSECTION. THEREFORE, THE TIBIA HAD TO BE RESECTED 2MM OVER PLAN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 17774245 ↗
• InjuryMay 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A LEFT TKA SURGERY, THE SURGEON HAD TO TAKE AN ADDITIONAL +2 FROM THE DISTAL, +2 FROM THE TIBIA, AS WELL AS DOWNSIZE, SINCE THE VIS ADPT GUIDE KIT JII DEVICE WAS A BAD FIT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A MANUAL INSTRUMENTS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 17008423 ↗
• MalfunctionMay 16, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TIBIAL BLOCK OF A VIS ADPT GUIDE KIT JII DID NOT FIT WELL AT ALL. THERE WAS A LARGE AMOUNT OF SPACE BETWEEN THE ANTERIOR TIBIA AND THE TIBIAL VISIONAIRE BLOCK. ALSO, STANDARD INSTRUMENTATION WAS USED ON THE TIBIA, BECAUSE SURGEONS DID NOT TRUST THE BLOCK WITH IT FITTING SO POORLY. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943205 ↗
• InjuryMar 16, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT, DURING A VISIONAIRE-ASSISTED TKA, THE SURGEON WENT TO USE THE CUTTING BLOCK AND NOTICED THAT THE HOLES WERE NOT LINING UP PROPERLY. THE SALES REP NOTICED THAT THE BLOCK WAS A LEGION AND NOT JOURNEY II, EVEN THOUGH THE BLOCK AND PACKAGING WERE LABELED AS SUCH. THE ISSUE WAS RECOGNIZED AFTER THE DISTAL CUT WAS MADE AND THE NOTED SIZE CUTTING BLOCK DID NOT SEEM TO LINE UP CORRECT WITH THE HOLES FROM THE VISIONAIRE BLOCK. THE SALES REP RECHECKED THE SURGICAL PLAN AND NOTICED THE PLANNED IMPLANT WAS FOR LEGION AND NOT JOURNEY II. FROM THAT POINT, TWO ADDITIONAL BONE HOLES WERE MADE TO FIT THE JOURNEY II TRADITIONAL INSTRUMENTATION TO SIZE THE FEMUR AND MOVED FORWARD. TRADITIONAL INSTRUMENTATION WAS USED FOR THE TIBIA. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.

  Patient problems: Rupture

  MAUDE report 16554410 ↗
• InjuryDec 6, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE USING THE VIS ADPT GUIDE KIT JII, THE FEMORAL BLOCK WAS A POOR FIT. THE PATIENT'S TROCHLEAR GROOVE WAS NOT A GOOD MATCH WITH THE BLOCK, THE PATIENT'S ANATOMY WAS SHALLOW COMPARED TO THE CUTTING BLOCK. THE DOCTOR CHOSE TO REMOVE A FEW OSTEOPHYTES IN ORDER TO TRY TO GET A BETTER FIT, BUT THERE WAS A SIGNIFICANT ANTERIOR GAP. SURGEON USED THE ALIGNMENT GUIDE AND DROP ROD TO CONFIRM ALIGNMENT WAS ADEQUATE. SURGEON MADE THE VISIONAIRE GUIDED FEMUR CUT, THEN TOOK A +2MM DISTAL RECUT. THE ANTERIOR CUT AND ROTATION WERE ADEQUATE FOR THE 5-IN-1 CUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923610 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA, USING A VIS ADPT GUIDE KIT JII, THE SURGEON FELT THAT THE TIBIA WAS TOO EXTERNALLY ROTATED AND OVERSIZED. THE SURGEON ALSO FELT THAT THE FEMUR WAS OVERLY FLEXED. SURGERY WAS PERFORMED, WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THE PATIENT HAD A SLIGHT PAIN POST OPERATION.

  Patient problems: Arthralgia; Pain; Unspecified Tissue Injury

  MAUDE report 15434061 ↗
• InjuryAug 3, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHILE USING A VISIONAIRE ADAPTIVE GUIDE KIT - JOURNEY II THE ANTERIOR FEMORAL CUT WAS NOT FLUSH, LEAVING THE ANTERIOR FLANGE OFF THE CORTEX PROXIMALLY. THE TIBIA CUT WAS VERY AGGRESSIVE REQUIRING AN 18 MM POLY TO STABILIZE THE JOINT SPACES. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Laceration(s); Unspecified Tissue Injury

  MAUDE report 15157053 ↗
• InjuryJul 26, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A TKA SURGERY AFTER CUTTING THROUGH THE VISIONAIRE BLOCK, WHEN THE SURGEON PUT THE METAL-DISTAL CUT BLOCK ON THE PINS FROM THE VISIONAIRE BLOCK, HE FOUND OUT THAT IT TOOK ABOUT 4 MM MORE BONE ON THE DISTAL CUT. THE SURGEON ALWAYS DOES A "CLEAN UP CUT" WITH THE METAL DISTAL CUT BLOCK AND HE DID NOT CATCH IT UNTIL HE ALREADY TOOK SOME BONE, SO HE HAD TO GO WITH IT. THEY CHECKED TO MAKE SURE THE PINS WERE IN THE CORRECT HOLES ON THE DISTAL CUTTING BLOCK. THE DOCTOR THINKS THERE WAS A FEW EXTRA MILLIMETERS THAN USUAL BETWEEN THE CUTTING SLOT AND THE PIN HOLES ON THE VISIONAIRE BLOCK. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. THE ONLY KNOWN MODIFICATION DONE ON THE SURGICAL PROCEDURE WAS USING A LARGER POLYETHENE INSERT THAN INITIALLY PLANNED. PATIENT IS CURRENTLY HEALTHY.

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

  MAUDE report 15105636 ↗
• InjuryFeb 10, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIBIAL CUTTING BLOCK FROM THE (B)(6) KIT JII WAS IN VALGUS. THE EXTRA-MEDULLARY GUIDE HAD TO BE USED TO PROCEED. IT IS UNKNOWN IF SURGERY WAS DELAYED AND IF PATIENT WAS HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510645 ↗
• InjuryNov 12, 2021Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY A VIS ADPT GUIDE KIT JII THE TIBIA CUT BLOCK SEEMED TO BE FRAYING WHEN THE SURGEON CUT THROUGH IT. THIS CAUSED A PIECE OF THE BLOCK TO FLY OFF INSIDE THE CUT SLOT. THE 5-1 FEMUR CUTTING BLOCK ALSO DID NOT FIT VERY WELL INTO THE PRE DRILLED DISTAL HOLES FROM THE VISIONAIRE BLOCKS, ALTHOUGH THE SURGEON WAS ABLE TO MAKE IT WORK. SURGERY WAS FINISHED WITH THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805797 ↗
• InjuryOct 4, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, THE TIBIAL BLOCK WAS CLOSE TO 20 DEGREES IN VALGUS, SO THE VIS ADPT GUIDE KIT JII WAS UNUSABLE. HAD TO USE THE EXTRAMEDULLARY TIBIA GUIDE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568034 ↗
• InjurySep 16, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE VIS ADPT GUIDE KIT JII DID NOT FIT VERY WELL. THE PATIENT'S FEMUR WAS EXTREMELY FLEXED AFTER MAKING THE DISTAL CUT. ALSO, THE TIBIA ALIGNMENT WAS OFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12481959 ↗
• InjuryJul 28, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A VIS ADPT GUIDE KIT JII DID NOT SEEM TO CORRESPOND TO THE SURGICAL PLAN. PATIENT HAD A SIGNIFICANT FLEXION CONTRACTURE. IT WAS DISCUSSED TAKING AN EXTRA 2 MM FROM THE BEGINNING OF THE SURGERY. SURGERY WAS RESUMED, AFTER A MINUTES DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243574 ↗
• InjuryJun 29, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA SURGERY THE DOCTOR PINNED THE VISIONAIRE FEMORAL GUIDE INTO PLACE AND MADE HIS DISTAL FEMORAL CUT. WHEN HE PUT THE SIZE 4 PLANNED SIZE CUTTING GUIDE INTO THE PRE DRILLED HOLES IT SEEMED TO HAVE PUT THEM INTO EXTREME EXTERNAL ROTATION AND WOULD HAVE TAKEN OFF AND ESTIMATED 15+ MM OF BONE OFF THE POSTERIOR MEDIAL SIDE. HE THEN DECIDED TO CHANGE TO CONVENTIONAL INSTRUMENTATION AND SIZED THE FEMORAL TO A SIZE 5 AND THE ROTATION WAS PUT CORRECTLY TO 3 DEGREES OF EXTERNAL ROTATION. THEY THEN USED THE VISIONAIRE TIBIAL CUTTING GUIDE AND SEEMED TO LINE UP CORRECTLY AND MADE THE RESECTION. WHEN THEY CHECKED THE PRE DRILLED TIBIAL ROTATION, IT AGAIN WAS EXTREMELY EXTERNALLY ROTATED. WE THEN CORRECTED THAT INTER-OP AND SIZED IT UP ONE SIZE FROM A 2 TO A 3. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086529 ↗
• InjuryJun 29, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA SURGERY THE DOCTOR PINNED THE VISIONAIRE FEMORAL GUIDE INTO PLACE AND MADE HIS DISTAL FEMORAL CUT. WHEN HE PUT THE SIZE 4 PLANNED SIZE CUTTING GUIDE INTO THE PRE DRILLED HOLES IT SEEMED TO HAVE PUT THEM INTO EXTREME EXTERNAL ROTATION AND WOULD HAVE TAKEN OFF AND ESTIMATED 15+ MM OF BONE OFF THE POSTERIOR MEDIAL SIDE. HE THEN DECIDED TO CHANGE TO CONVENTIONAL INSTRUMENTATION AND SIZED THE FEMORAL TO A SIZE 5 AND THE ROTATION WAS PUT CORRECTLY TO 3 DEGREES OF EXTERNAL ROTATION. THEY THEN USED THE VISIONAIRE TIBIAL CUTTING GUIDE AND SEEMED TO LINE UP CORRECTLY AND MADE THE RESECTION. WHEN THEY CHECKED THE PRE DRILLED TIBIAL ROTATION, IT AGAIN WAS EXTREMELY EXTERNALLY ROTATED. WE THEN CORRECTED THAT INTER-OP AND SIZED IT UP ONE SIZE FROM A 2 TO A 3. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086387 ↗
• InjuryJun 23, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY SURGERY, A VISIONAIRE ADAPTIVE GUIDE JII FEMUR BLOCK DID NOT FIT THE ANATOMICAL SITE. FEMUR WAS UPSIZED 2 SIZES TO SIZE 8 AND ROTATION WAS OFF. SURGERY WAS PERFORMED WITH A CHANGE IN THE SURGICAL TECHNIQUE, AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054199 ↗
• MalfunctionMay 31, 2021Failure to Align; Failure to Align

  IT WAS REPORTED DURING THE TKA PROCEDURE, THAT THE TIBIA CORONAL ALIGNMENT WAS OFF. THE INCIDENT OCCURRED INSIDE THE PATIENT. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN AND WAS USED A BACKUP FROM SMITH & NEPHEW TO FINISH THE SURGERY. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907702 ↗