JOURNEY 74027272Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556179765), received between Jun 13, 2017 and May 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Contamination” (1 report).

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 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON A UNKNOWN DATE. THE PATIENT EXPERIENCED STABILITY ISSUES AND THE POST OF THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 10MM WAS FOUND BROKEN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH A 7-8 10MM BCS INSERT WAS RE-IMPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19343443 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON THE (B)(6) 2015, THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6) 2017 TO EXPLANT THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 10MM. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 13407424 ↗
• InjuryJun 13, 2017Contamination

  IT WAS REPORTED THAT FOLLOWING TKA PATIENT DEVELOPED A KNEE INFECTION WHICH WAS SOLVED WITH ANTIBIOTIC THERAPY AND SURGICAL APPROACH WHICH INCLUDED EXCHANGE OF TIBIAL INSERT. RIGHT KNEE COMPLICATION INCLUDED DRAINAGE, SWELLING AND FLU-LIKE SYMPTOMS. ASPIRATE OF RIGHT KNEE EFFUSION REVEALED INFECTION - (B)(6). EVENT IS RESOLVED AND PATIENT WAS DOING WELL ON FOLLOW-UP APPOINTMENT (B)(6) 2012.

  Patient problems: Unspecified Infection

  MAUDE report 6636213 ↗

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-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-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