JOURNEY 74018608Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 03596010557094), received between Apr 15, 2019 and Jun 10, 2026 — classified as 3 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Break” (39 reports).

3 other recalls cover devices cleared under the same FDA submission (K111711); they may or may not involve this specific model.

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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FLEX-EXT SPACER 9MM BROKE IN TWO WHILE TRYING TO EXCHANGE FOR A 10MM SPACER. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, 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 25459986 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF THE JOURNEY FLEX-EXT SPACER 9MM BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905838 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY FLEX-EXT SPACER 9MM BLOCK BROKE DURING TRIALING. NO PIECES WERE LEFT IN PATIENT. ALL WERE ACCOUNTED FOR AND WILL BE RETURNED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459888 ↗
• MalfunctionOct 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN MEASURING GAPS, ONE (1) JOURNEY FLEX-EXT SPACER 9MM SPLIT IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23262591 ↗
• MalfunctionAug 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FLEX-EXT SPACER 9MM FRACTURED DURING ITS REMOVAL. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913262 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY FLEX-EXT SPACER 9MM BROKE WHILE TRIALING. 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 22671671 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FLEX-EXT SPACER 9MM BROKE DUE TO IMPACT. NO PIECES FELL INSIDE THE WOUND AND THEY WERE COUNTED. 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 22303393 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, THE (1) JOURNEY FLEX-EXT SPACER 9MM FRACTURED WHEN INSERTING IT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749013 ↗
• MalfunctionJan 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE JOURNEY FLEX-EXT SPACER 9MM BROKE IN HALF. NOTHING FELL INTO THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461336 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE ORANGE JOURNEY FLEX-EXT SPACER 9MM BROKE IN HALF. THE PIECES WERE EASILY RETRIEVED BY HAND, EXTRA CARE WAS TAKEN TO ASSURE ALL PIECES WERE THERE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED, ALL THE PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240350 ↗
• MalfunctionJul 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) JOURNEY FLEX-EXT SPACER 9MM BROKE INTO TWO PIECES INSIDE OF THE PATIENT. 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 17268981 ↗
• MalfunctionJun 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, PART OF SHIM FRACTURED OFF AFTER REMOVING FROM ONE (X1) JOURNEY FLEX-EXT SPACER 9MM. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243120 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A JOURNEY FLEX-EXT SPACER 9MM BROKE DURING USE. 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 16986922 ↗
• MalfunctionMay 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY FLEX-EXT SPACER 9MM DEVICE CRACKED IN HALF WHEN PLACING IT IN THE SPACER BLOCK. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY BUT IT IS UNKNOWN HOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854363 ↗
• MalfunctionSep 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT A JOURNEY FLEX-EXT SPACER 9MM SPACER BROKE IN HALF. 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 15500395 ↗
• MalfunctionSep 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, JOURNEY FLEX-EXT SPACER 9MM HAS A BROKEN PIECE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467762 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT A JOURNEY FLEXION EXTENSION SPACER 9MM WAS NOTICED TO BE CHIPPING AND WORN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393392 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FLEX-EXT SPACER 9MM WAS FOUND CRACK. LATER, DEVICE WAS INSPECTED TO VERIFY ITS STRUCTURAL INTEGRITY BEFORE HANDING UP TO SURGEON. AT WHICH POINT THE JOURNEY FLEX-EXT SPACER 9MM SNAPPED. SURGERY WAS PERFORMED WITHOUT ANY DELAY WITH A S+N BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. DEVICE WAS DISCARDED AT END OF CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392664 ↗
• MalfunctionSep 5, 2022Break; Break

  IT WAS REPORTED THAT A JOURNEY FLEX-EXT SPACER 9MM BROKE OFF WHILE BEING PUT INTO BLACK THE BLOCK. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355144 ↗
• MalfunctionSep 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE JOURNEY FLEX-EXT SPACER 9MM HAS A BROKEN PIECE. 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 15341916 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT THE JOURNEY FLEX-EXT SPACER 9MM BROKE IN THE WASHER. AS THIS WAS NOTICED DURING SETUP, THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331643 ↗
• MalfunctionAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT A JOURNEY FLEX-EXT SPACER 9MM BROKE INTO TWO PIECES. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15267087 ↗
• MalfunctionAug 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE JOURNEY FLEX-EXT SPACER 10MM, THE JOURNEY FLEX-EXT SPACER 9MM AND THE GII MIS TIB BLCK ALIGN ROD WERE WORN DUE TO WEAR. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICES WITHOUT DELAY. THE PATIENT WAS NOT HARMED. INITIALLY IT WAS REPORTED THAT THE JOURNEY FLEX-EXT SPACER 10MM AND THE JOURNEY FLEX-EXT SPACER 9MM WERE WORN, BUT DURING INVESTIGATION IT WAS NOTICED THAT BOTH DEVICES ARE BROKEN IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15231457 ↗
• MalfunctionAug 1, 2022Break; Break

  IT WAS REPORTED THAT A JOURNEY FLEX-EXT SPACER 9MM CAME BACK BROKEN AND WAS MISSING THE MAJORITY OF THE BROKEN PIECES. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142950 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE JOURNEY FLEX-EXT SPACER 9MM BROKE IN HALF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15136371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5