JOURNEY 74032147Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556001448), received between Dec 29, 2023 and May 14, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Fracture

  IT WAS REPORTED THAT, DURING A LEFT TKA SURGERY, ONE (1) JRN II BCS CAM TRL SZ 7 LT FRACTURED WHILE INSERTING IT INTO THE FEMORAL TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174117 ↗
• MalfunctionJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE UPPER TIP OF JRN II BCS CAM TRL SZ 7 LT BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INTO THE INCISION. 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 22185777 ↗
• MalfunctionOct 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE CORNER OF ONE (1) JRN II BCS CAM TRL SZ 7 LT BROKE OFF AND NO LONGER ENGAGED WITH THE FEMORAL TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20572348 ↗
• MalfunctionMar 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY THE TAG ON ONE (1) JRN II BCS CAM TRL SZ 7 LT WAS BROKEN OFF. 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 18937843 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA THE TAB OF A JRN II BCS CAM TRL SZ 7 LT WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 18419435 ↗

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