JOURNEY 74027255Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556179567), received between Dec 15, 2017 and Feb 17, 2020 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2020Break; Break

  IT WAS REPORTED REVISION OF JOURNEY II BCS WAS PERFORMED DUE TO THE BREAKAGE OF THE INSERT¿S POST.

  Patient problems: Injury

  MAUDE report 9716276 ↗
• InjuryAug 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SEROSANGUINEOUS DRAINAGE FROM MID TKA INCISION WAS NOTICED. THE ADVERSE EVENT WAS RESOLVED BY IRRIGATING AND PERFORMING DEBRIDEMENT.

  Patient problems: Injury

  MAUDE report 8904422 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ARTHROFIBROSIS RIGHT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED FOR WHICH SUBJECT WAS HOSPITALISED.

  Patient problems: Injury

  MAUDE report 8536324 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT SUFFERED FROM DERMATITIS SINCE TWO WEEKS AFTER THE KNEE REPLACEMENT ON BOTH LEGS. PATIENT IS WILLING TO OBTAIN A METAL ALLERGY TEST ((B)(6) TESTING) FROM A MEDICAL INSTITUTE IN (B)(6). PATIENT HAS RECEIVED MULTIPLE DUPIXENT INJECTIONS, ONCE EVERY TWO WEEKS SINCE (B)(6) 2017 FOR RASH AND ITCHING.

  Patient problems: Skin Irritation

  MAUDE report 7519647 ↗
• InjuryMar 4, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STIFFENING OF THE KNEE.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 7312359 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE JOINT ASPIRATION TO RESOLVE A PAINFUL RIGHT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 7123350 ↗

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