JOURNEY 74035271Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556157787), received between Nov 5, 2019 and Aug 26, 2025 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE INTO SEVERAL PIECES DURING TRIALING. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897023 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE IN HALF WHILE TRIALING WHILE DOING HANDLING ACTIVITIES. 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 20893695 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ON TOP OF ONE (1) JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT NEXT TO THE STEAM, THERE WAS A CHIP THAT CAME OUT AND MADE A HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991518 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT DEVICE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, BUT IT IS UNKNOWN HOW. ALL PIECES WERE REMOVED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358326 ↗
• MalfunctionFeb 15, 2023Crack; Fracture; Crack; 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 9MM RT CRACKED AND 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 16379618 ↗
• MalfunctionDec 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE WHILE TRIALING FOR THE GAP BALANCE. 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 15895521 ↗
• MalfunctionOct 14, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING TKA, A FRAGMENT OF INSERT OF A JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE AWAY WHEN REMOVING FROM BASE PLATE. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611005 ↗
• MalfunctionJun 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE DURING WASH. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14845761 ↗
• MalfunctionJun 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741410 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE DURING SURGERY. IT IS UNKNOWN IF INTERNAL OR EXTERNAL TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14417473 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT BROKE IN CASE. IT IS UNKNOWN WHEN THIS ISSUE HAPPENED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14417170 ↗
• MalfunctionMar 31, 2022Crack; Crack

  IT WAS REPORTED THAT, THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT WAS CRACKED WHEN RESETTING TRAYS. 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 13961860 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT WAS DAMAGED. THE DEVICE IS BROKEN AND CHIPPED, AND ALSO HAVE SOME CRACKS. INCIDENT WAS NOTICED DURING A TKA WHILE USING INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326547 ↗
• MalfunctionJan 27, 2021Crack; Crack

  IT WAS REPORTED THAT THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT IS CHIPPED AND CRACKED. INCIDENT OCCURRED DURING A STANDARD OFFICE EFIP INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS 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 11234604 ↗
• InjuryJan 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 9MM RIGHT SNAPPED DURING TRIALING INSIDE OF THE PATIENT AND NO PIECES WERE LOST INSIDE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174022 ↗
• MalfunctionJan 5, 2021Crack; Crack

  IT WAS REPORTED THAT, ARTICULAR INSERT TRIAL DEVICE IS CRACKED. NO CASE INVOLVED; THEREFORE, 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 11118765 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT THE SIZ 7-8 9MM RIGHT BCS INSERT TRIAL THAT HAS CRACKED. THIS WAS DISCOVERED WHILE ASSEMBLING SETS AND WAS NOT INVOLVED IN A SURGERY SO DID NOT AFFECT ANY PATIENT. NO CASE 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 11090157 ↗
• MalfunctionNov 4, 2020Break; Break

  IT WAS REPORTED THAT THE BOTTOM OF THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 9MM RIGHT IS DAMAGED (CHIPPED, CRACKED). THERE WAS NO CASE INVOLVED AS THIS WAS FOUND UPON INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10784897 ↗
• InjuryNov 2, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT WHILE TRIALING THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM RT THE SURGEON HAD TO USE A SURGICAL INSTRUMENT TO PUSH THE TRIAL INTO THE CORRECT PLACE. THE TRIAL WASN¿T SITTING INSIDE THE TIBIA LIKE IT SHOULD, THIS RESULTED IN THE DEGRADATION OF THE JOURNEY INSERT. THE INSERT WILL NO LONGER CLICK INTO PLACE PROPERLY AND IS NOT RELIABLE IN TERMS OF PATIENT TRIALING. A DELAY OF LESS THAN 30 MIN WAS REPORTED. A S&N BACK UP DEVICE WAS AVAILABLE. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10775663 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSERT TRIAL BROKE IN HALF DURING RANGE OF MOTION. IT BROKE INSIDE THE PATIENT, AND ALL PIECES WERE RECOVERED. S+N BACK-UP DEVICE AVAILABLE, NO DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282322 ↗

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