JOURNEY 74018603Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 03596010557087), received between Apr 7, 2019 and Jun 12, 2026 — classified as 3 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Break” (63 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE WHITE PIECES OF TWO (2) JOURNEY FLEX EXT BLOCK STDS BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494434 ↗
• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FLEX EXT BLOCK STD FRACTURED. NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130766 ↗
• MalfunctionMay 3, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE WHITE ATTACHMENT PIECES INSIDE THE JOURNEY FLEX EXT BLOCK STD, WERE BROKEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064271 ↗
• MalfunctionApr 30, 2025Fracture; Separation Failure; Material Deformation; Mechanical Jam; Fracture; Separation Failure; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING TKA SURGERY THE WHITE CLIP INSIDE OF ONE (1) JOURNEY FLEX EXT BLOCK STD BROKEN RENDERING THE INSTRUMENT UNUSABLE. IT WAS DETERMINED TO BE FAULTY DURING AN ATTEMPT TO REMOVE THE ORANGE SPACER FROM THE BLACK SPACER BLOCK. THE ORANGE SPACER WAS JAMMED AND REQUIRED OVER 10 MINUTES TO REMOVE WITH CONSIDERABLE DIFFICULTY. UPON REMOVAL, IT WAS OBSERVED THAT ONE OF THE TWO WHITE RINGS INSIDE THE BLACK SPACER BLOCK WAS BROKEN. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS 10 MIN DELAYED WHILST TRYING TO REMOVE THE ORANGE SPACER. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933775 ↗
• MalfunctionMar 20, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE WHITE RING OF ONE (1) JOURNEY FLEX EXT BLOCK STD CAME OUT OF FLEXION BLOCK, SPACER WILL NOT SNAP IN. ALL PIECES RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT 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 21652701 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE INNER PIECES OF FIVE (5) JOURNEY FLEX EXT BLOCK STD WERE BROKEN, SO THE ORANGE PIECES CAN NOT CLICK IN. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS PROCEDURAL DELAY, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724326 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE RING FROM ONE (1) JOURNEY FLEX EXT BLOCK STD THAT HOLD SPACERS IN PLACE BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528108 ↗
• MalfunctionAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY FLEX EXT BLOCK STD CRACKED IN HALF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937654 ↗
• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKR, IT WAS NOTICED THAT A PIECE OF THE INNER WHITE PLASTIC OF A JOURNEY FLEX EXT BLOCK STD HAD COME OFF. IT IS UNKNOWN IF THIS WAS A BREAKAGE. THERE WAS NO DELAY BUT IT'S UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358053 ↗
• MalfunctionOct 18, 2023Break; Break

  WAS REPORTED THAT DURING A TKA SURGERY, A JOURNEY FLEX EXT BLOCK STD HAD THE RINGS BROKEN OR GONE, AND WOULD NOT HOLD ORANGE SPACERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962259 ↗
• MalfunctionOct 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, A JOURNEY FLEX EXT BLOCK STD HAD THE RINGS BROKEN OR GONE, AND WOULD NOT HOLD ORANGE SPACERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962253 ↗
• MalfunctionOct 9, 2023Break; Break

  TYPO: IT WAS REPORTED THAT, DURING A TKA SURGERY THREE (3) JOURNEY FLEX EXT BLOCK STD HAD THE RINGS BROKEN OR GONE, AND WOULD NOT HOLD ORANGE SPACERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND NO PIECES FELT INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895420 ↗
• InjuryFeb 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JOURNEY FLEX EXT BLOCK STD SNAPPED. THE PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372935 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE BLACK GAP CHECKERS RINGS OF THE JOURNEY FLEX EXT BLOCK STD DEVICE WERE FOUND TO BE BROKEN, SO THE ORANGE PIECES WILL NOT CLIP IN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247323 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE BLACK GAP CHECK RING OF THE JOURNEY FLEX EXT BLOCK STD DEVICE WAS FOUND TO BE BROKEN, SO THE ORANGE PIECES CANNOT SNAP IN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247111 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE BLACK GAP CHECKERS RINGS OF THE JOURNEY FLEX EXT BLOCK STD DEVICE WERE FOUND TO BE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195901 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FLEX EXT BLOCK STD BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134897 ↗
• MalfunctionNov 13, 2022Break; Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FLEX EXT BLOCK STD BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786287 ↗
• MalfunctionOct 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC RING INSIDE THE JOURNEY FLEX EXT BLOCK STD WAS BROKEN. IT PREVENTED THE SPACERS FROM LOCKING IN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544556 ↗
• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A JOURNEY FLEX EXT BLOCK STD HAS THE WHITE PLASTIC THAT HOLDS THE INSERT BROKE AND WON´T HOLD INSERTS. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363272 ↗
• MalfunctionSep 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, JOURNEY FLEX EXT BLOCK STD INNER PLASTIC RING BROKE. NO PIECES FELL INTO THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353185 ↗
• MalfunctionAug 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE SETTING UP FOR A TOTAL KNEE ARTHROPLASTY THE LOCKING RING OF A JOURNEY FLEX EXT BLOCK STD WAS NOTICED TO BE BROKEN. ADDITIONALLY, THE LOCKING RING WAS REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292759 ↗
• MalfunctionJul 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE JOURNEY FLEX EXT BLOCK STD WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052075 ↗
• MalfunctionJun 18, 2022Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT AFTER A TKA SURGERY THE RINGS OF THREE (3) JOURNEY FLEX EXT BLOCK STD WERE EITHER MISSING OR BROKEN. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739799 ↗
• MalfunctionJun 11, 2022Break; Break

  IT WAS REPORTED THAT THE JOURNEY FLEX EXT BLOCK STD WOULD NO LONGER HOLD THE ORANGE SPACER SHIMS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. UPON INVESTIGATION OF THE DEVICE, IT WAS NOTICED THAT BOTH OF THE RETAINING RINGS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14663061 ↗