JOURNEY 74018611Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010557124), received between Jan 4, 2021 and Dec 6, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) JOURNEY FLEX-EXT SPACER 11MM FRACTURED WHILE PULLING OFF TRIAL. NO PIECES FELL INTO 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 15923618 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT A JOURNEY FLEX-EXT SPACER 11MM IS BROKE INTO TWO PIECES. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815033 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT THE SHIM OF A JOURNEY FLEXION EXTENSION SPACER 11MM BROKE IN HALF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368574 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT A JOURNEY FLEXION EXTENSION SPACER 11MM WAS FOUND BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314906 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY FLEX-EXT SPACER 11MM BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886841 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT, THE JOURNEY FLEX-EXT SPACER 11MM BROKE. 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 11114211 ↗

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