JOURNEY 74035221Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556156735), received between Jul 24, 2020 and Nov 14, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHILE REMOVING FROM TRIALING PROCESS ONE (1) JRNY II BCS ART ISRT TRL SZ 1 2 9MM LT BROKE IN TWO PARTS. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563044 ↗
• MalfunctionMay 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE PLASTIC ON THE UNDERSIDE OF THE JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT BROKE. 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 22079731 ↗
• MalfunctionNov 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT FRACTURED IN HALF WHILE LOCKING ON THE TIBIA. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED. 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 15777528 ↗
• MalfunctionJul 20, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT APPEARS TO BE BROKEN IN THE FRONT AND THE BOTTOM IS SEVERELY WORN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070141 ↗
• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 9MM LEFT IS CRACKED/CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13093500 ↗
• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 9MM LEFT IS CRACKED/CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13093076 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861317 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT WAS CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861024 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487959 ↗
• MalfunctionMay 31, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE A TKA SURGERY, THE JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT PLASTIC WAS CRACK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907628 ↗
• MalfunctionApr 20, 2021Break; Break

  REF#(B)(4). IT WAS REPORTED THAT, THE DEVICES IN THE LIST WERE FOUND BROKEN OR CRACKED. THEY WERE USED BY CUSTOMER BEFORE DEFECT WAS FOUND IN THE WAREHOUSE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. CASE NUMBER/PART NUMBER/JAPAN REF NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693280 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT ((B)(4)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT ((B)(4)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM ((B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM ((B)(4)),JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM ((B)(4)), THREE HONEYCOMB ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT ((B)(4)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER ((B)(4)) AND SCREWDRIVER RELEASE HANDLE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593400 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT WAS NOTICED TO BE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593373 ↗
• MalfunctionMar 24, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING INSPECTION, IT WAS NOTICED THAT TWO JRNY II BCS ART ISRT TRL HAD CRACKS/GOUGES IN PLASTIC. THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566381 ↗
• MalfunctionDec 21, 2020Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050836 ↗
• MalfunctionDec 21, 2020Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050739 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT, FOR A JOURNEY II BCS ART INSERT TRIAL SIZE 1-2 9MM LEFT, THE INSERT WAS CHIPPED. 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 10982809 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH GOUGES/CRACKS/SCRATCHES. NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321917 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS ARTICULAR INSERT WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10318376 ↗

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