JOURNEY 74032136Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556001745), received between Jul 16, 2020 and Apr 15, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN INSERTING THE JRN II BCS CAM TRL SZ 6 RT INTO THE FEMORAL TRIAL, A LATERAL METAL PIECE BROKE OFF. IT IS UNKNOWN IF BROKEN PIECES FELL DOWN INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21845668 ↗
• MalfunctionNov 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN REMOVING THE ANTERIOR FIN, THE JRN II BCS CAM TRL SZ 6 RT BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074934 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FIN/WING ON THE LEFT SIDE OF THE JOURNEY II BCS CAM TRIAL SIZE 6 RIGHT BROKE OFF OUTSIDE OF THE PATIENT. IT IS UNKNOWN IF ANY PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697475 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE LEFT SIDE OF THE CAM OF A JOURNEY II BCS CAM TRIAL SIZE 6 RIGHT BROKE OFF OUTSIDE OF PATIENT. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729690 ↗
• MalfunctionMar 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE JOURNEY II BCS CAM TRIAL SIZE 6 RIGHT HAS A CHIP AT FEMORAL ATTACHMENT POINT. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552396 ↗
• MalfunctionJan 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TAB OF THE JRN II BCS CAM TRL SZ 6 RT BROKE OFF. NO PIECES FELL INTO PATIENT WOUND. PROCEDURE FINISHED WITH SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11185193 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT THIS CUTTING BLOCK BROKE DURING IMPACTION PROCESS. DEVICE BROKE OUTSIDE THE PATIENT, NO PIECES FELL INSIDE THE PATIENT AND ALL THE PIECES WERE RECOVERED. PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO DELAYS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286386 ↗

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