JOURNEY 74035243Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556156988), received between Jul 24, 2020 and May 29, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMay 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II BCS ART ISRT TRL SZ 3-4 11MM LT FRACTURED ON THE SIDE WHILE IT WAS BEING REMOVED FROM THE TIBIAL TRIAL. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACKUP DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017330 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 3-4 11MM LT IS CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064808 ↗
• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT THE JRNY II BCS ART ISRT TRL SZ 3-4 11MM LT WAS CRACKED. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095635 ↗
• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 3-4 11MM LEFT BROKE WHILE TRIALING. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974622 ↗
• MalfunctionJan 27, 2021Crack; Crack

  IT WAS REPORTED THAT THE JRNY II BCS ART ISRT TRL SZ 3-4 11MM LT 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 11234605 ↗
• MalfunctionNov 23, 2020Break; Break

  IT WAS REPORTED THAT ON A JOURNEY II BCS ART INSERT TRIAL SIZE 3-4 11MM LEFT, THE PLASTIC WAS SHREDDING AND BREAKING OFF. THIS OCCURRED AFTER TKA PROCEDURE .PROCEDURE FINISHED WITH THE SAME DEVICE. NO HARM OR INJURY REPORTED ON PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886542 ↗
• 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 10322079 ↗

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