JOURNEY 74018610Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03596010557117), received between Feb 18, 2019 and May 6, 2024 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) JOURNEY FLEX-EXT SPACER 10MM BROKE. IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248820 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY FLEX-EXT SPACER 10MM CRACKED DOWN THE MIDDLE. NO PIECES FELL INSIDE THE PATIENT. 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 18987819 ↗
• MalfunctionAug 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A JOURNEY FLEX-EXT SPACER 10MM BROKE. HOWEVER, ALL PIECES WERE ACCOUNTED FOR AND DID NOT REQUIRE RETRIEVAL FROM THE WOUND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651469 ↗
• MalfunctionNov 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE JOURNEY FLEX-EXT SPACER 10MM BROKE WHEN IMPACTED. ALL PIECES WERE RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, HOWEVER THERE WAS NO DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777478 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE JOURNEY FLEX-EXT SPACER 10MM BROKE IN HALF IN THE WASH. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411934 ↗
• MalfunctionAug 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE JOURNEY FLEX-EXT SPACER 10 MM, THE JOURNEY FLEX-EXT SPACER 9 MM 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 10 MM AND THE JOURNEY FLEX-EXT SPACER 9 MM 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 15214357 ↗
• MalfunctionJun 22, 2022Break; Break

  IT WAS REPORTED THAT, A JOURNEY FLEX-EXT SPACER 10MM BROKE IN HALF. AS THIS WAS NOTICED DURING SET UP OR INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777474 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT WHEN THE JOURNEY FLEXION EXTENSION SPACER 10MM WAS PICKED UP IT WAS FOUND TO BE BROKEN. 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 14655191 ↗
• MalfunctionMay 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FLEX-EXT SPACER 10MM SNAPPED IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO DELAY WAS REPORTED. IT IS ALSO UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14507847 ↗
• MalfunctionMay 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, THE JOURNEY FLEX-EXT SPACER 10 MM BROKE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. SINCE THE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342723 ↗
• MalfunctionMar 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE PLASTIC PLATE OF A JOURNEY FLEXION EXTENSION SPACER 10MM CRACKED WHILE IMPACTING, ALL PIECES WERE RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY OR HARM TO THE PATIENT WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13814659 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A JOURNEY FLEXION EXTENSION SPACER 10MM SNAPPED IN HALF DURING IMPACTION, OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214269 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT, THE JOURNEY FLEX-EXT SPACER 10MM WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983484 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, A JOURNEY FLEXION EXTENSION SPACER 10MM BROKE IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY OR HARM TO THE PATIENT WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823750 ↗
• MalfunctionJun 23, 2021Crack; Crack

  IT WAS REPORTED THAT JOURNEY FLEX-EXT SPACER 10MM HAS A CRACKED SHIM. 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 12053777 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE DURING USE, WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587196 ↗
• MalfunctionMar 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A EFIP INSPECTION A JOURNEY FLEX-EXT SPACER 10MM SNAPPED IN HALF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478822 ↗
• MalfunctionMar 7, 2021Break; Break

  IT WAS REPORTED THAT, THE 10MM SPACER BROKE IN HALF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427225 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY FLEX-EXT SPACER 10MM WAS FOUND TO BE BROKEN DURING A STANDARD EFIP INSPECTION. THERE WERE NO REPORTED PROBLEMS FROM ANY CASES AND NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077958 ↗
• MalfunctionDec 6, 2020Break; Break

  IT WAS REPORTED THAT, A SPACER SNAPPED IN HALF. THE EVENT HAPPENED DURING TRANSPORTATION TO THE HOSPITAL. NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10955677 ↗
• MalfunctionNov 27, 2020Break; Break

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION OF TOTAL KNEE ARTHROPLASTY THE JOURNEY FLEX-EXT SPACER 10MM BROKE IN HALF. NO DELAY OR CASE INVOLVED. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10913355 ↗
• MalfunctionOct 20, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE SPACER BLOCK WAS SNAPPED WHEN REMOVED. IT WAS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10708305 ↗
• MalfunctionJan 6, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SPACER BROKE WHILE REMOVAL FROM PATIENT. IT IS UNKNOWN IF ANY PIECE WAS LEFT INSIDE THE PATIENT. A BACK UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553402 ↗
• MalfunctionFeb 18, 2019Break; Break

  IT WAS REPORTED THAT THE FLEX SPACER IS BROKEN. NO PIECES FELL INTO THE SURGICAL SITE, ALL PIECES ACCOUNTED FOR. S&N BACKUP WAS USED. NO DELAY TO PROCEDURE NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8348156 ↗

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