JOURNEY 74024214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556170816), received between Oct 3, 2018 and May 11, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, K230653); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT CORI ROBOTIC-ASSISTED TKA SURGERY PERFORMED ON (B)(6) 2023 WITH A JRNY II BCS SYSTEM, THE PATIENT NEEDED TO BE HOSPITALIZED FROM (B)(6) 2023 TO (B)(6)2023, DUE TO BOWEL OBSTRUCTION. DURING THE HOSPITALIZATION, THE PATIENT HAD A NASOGASTRIC TUBE INSERTED AND A CT SCAN OF THE ABDOMEN/ PELVIS. THIS ADVERSE EVENT WAS TREATED WITH MEDICATION THERAPY AND THE PATIENT HAS RECOVERED. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16911499 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RIGHT TOTAL KNEE ANKYLOSIS AND EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8834590 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT KNEE MANIPULATION WAS PERFORMED DUE TO ARTHROFIBROSIS STATUS POST RECENT POLYETHYLENE EXCHANGE

  Patient problems: Fibrosis; Injury

  MAUDE report 7931894 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. 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-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5