JOURNEY 74035272Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556157831), received between Jul 28, 2019 and Dec 20, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IN THE INSERTION PROCESS OF BEGINNING THE TRIAL PERIOD OF SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 7-8 10MM RT COMPLETELY AND PERFECTLY SNAPPED IN HALF, LEAVING NO REMNANTS OR PIECES BEHIND. IT WAS A CLEAN BREAK, THEN, IT WAS FULLY AND APPROPRIATELY REMOVED BY HAND. THERE WERE NO PIECES TO BE EXTRACTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE OF A DIFFERENT SIZE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20993862 ↗
• MalfunctionMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE POLY OF (1) JRNY II BCS ART ISRT TRL SZ 7-8 10MM RT, BROKE IN 3 PIECES WHILE BEING INSERTED FOR 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 16579991 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHILE GOING THROUGH RANGE OF MOTION ONE (1) JRNY II BCS ART ISRT TRL SZ 7-8 10MM RT 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 16380654 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE JRNY II BCS ART ISRT TRL SZ 7-8 10MM RT BROKE IN TWO. THERE WAS NO PIECES TO RECOVER. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462307 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 10MM RIGHT WAS BROKEN. SINCE THIS WAS NOTICED ON A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113771 ↗
• MalfunctionNov 25, 2021Crack; Crack

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 7-8 10MM RT CRACKED. SINCE THIS WAS AFTER PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874453 ↗
• MalfunctionJun 8, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 10MM RIGHT CRACKED WHILE INSTRUMENTS WERE OUTSIDE 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 11963043 ↗
• MalfunctionJan 28, 2021Break; Break

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY, OUTSIDE THE PATIENT, THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 10MM RIGHT HAS BROKEN IN TWO. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11246793 ↗
• MalfunctionJan 5, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA SURGERY, INSERT TRIAL DEVICE CRACKED DURING CASE TRIALING. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. 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 11118902 ↗
• InjuryJan 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE BOTH THE INSERT TRIAL AND THE LOCKING BUMPER BROKE DURING IMPACTION. ALL PIECES RECOVERED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11114854 ↗
• MalfunctionOct 7, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL WAS FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10642757 ↗
• MalfunctionOct 2, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10618910 ↗
• MalfunctionJul 28, 2019Break; Break

  IT WAS REPORTED THAT PART OF INSERT TRIAL BROKE OFF WHILE TRIALING. ALL PIECES WERE RECOVERED. S&N BACKUP DEVICE WAS AVAILABLE. NO INJURIES OR DELAYS REPORTED. NO MORE INFORMATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8834703 ↗

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