JOURNEY 74035252Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556157688), received between Feb 21, 2021 and Jun 7, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE POST OF A JRNY II BCS ART ISRT TRL SZ 5-6 10MM RT CRACKED AND BROKE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084154 ↗
• MalfunctionOct 26, 2022Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 5-6 10MM RT IS CHIPPED AND SCRATCHED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674888 ↗
• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT THE JRNY II BCS ART ISRT TRL SZ 5-6 10MM RT IS CHIPPED. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317279 ↗
• MalfunctionJan 17, 2022Break; Break

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 5-6 10MM RT IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267521 ↗
• MalfunctionJan 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT THE JRNY II BCS ART ISRT TRL SZ 5-6 10MM RT IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226040 ↗
• MalfunctionFeb 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED AFTER THE PROCEDURE DURING THE STERILIZATION PROCESS THAT THE BLACK DOTS WILL NOT COME OFF WHEN THE DEVICE CLEANED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356699 ↗

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