JOURNEY 74032137Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556001790), received between Dec 10, 2020 and Dec 2, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) JRN II BCS CAM TRL SZ 7 RT BROKE DURING IMPACTION. NOTHING WENT INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700230 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE WING OF ONE (1) JRN II BCS CAM TRL SZ 7 RT BROKE OFF WHILE IMPACTING IT INTO THE FEMORAL TRIAL. NO PIECE'S FALL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391777 ↗
• MalfunctionFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE METAL FLANGE ON THE RN II BCS CAM TRL SZ 7 RT BROKE OFF WHILE THE SURGEON WAS PLACING THE CAM TRIAL ON THE FEMUR TRIAL. THE FLANGE CAME OFF IN ONE PIECE AND IT WAS RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684546 ↗
• MalfunctionJan 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE SIDE PART OF ONE (1) JRN II BCS CAM TRL SZ 7 RT BROKE OFF WHEN IMPACTING. THE PIECE WAS FOUND, NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607753 ↗
• MalfunctionDec 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) JRN II BCS CAM TRL SZ 7 RT BROKE DURING TRIALING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383578 ↗
• MalfunctionOct 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JRN II BCS CAM TRL SZ 7 RT FLANGE BROKE OFF WHILE INSERTING. BROKEN PIECE WAS RETRIEVED AND DID NOT FALL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021229 ↗
• InjuryAug 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A JRN II BCS CAM TRL SZ 7 RT BROKE WHILE IMPACTING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317019 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS CAM TRIAL SIZE 7 RIGHT WAS FOUND CHIPPED. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS 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 10988355 ↗

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