JOURNEY 74027237Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556179314), received between Mar 11, 2019 and Mar 5, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY TKA, THE PATIENT PRESENTED INSTABILITY AND A REVISION SURGERY WAS PERFORMED TO EXPLANT A JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4-RIGHT 18MM. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 11423628 ↗
• InjuryMar 11, 2019Break; Break

  ON (B)(6) 2017 THE SUBJECT IS NOTED WITH A REVISION OF THE TOTAL KNEE ARTHROPLASTY AS A CONSEQUENCE OF HAVING A FALL. MEDICAL RECORDS DO NOT STATE DAMAGE TO STUDY KNEE; HOWEVER, IT IS NOTED THAT SUBJECT ON LEFT SIDE ¿SMASHED THE KNEE CAP AND THE FEMUR IN 3 PLACES¿. IT IS NOTED THAT DAMAGES TO THE RIGHT SIDE (STUDY SIDE) ARE MINOR AND THAT SUBJECT UNDERWENT MINOR REVISION SURGERY. DATE OF RESOLUTION IS (B)(6) 2017 AND POLY EXCHANGE WAS PERFORMED FOR WHAT IS NOTED TO BE INSTABILITY AND BREAKAGE OF THE IMPLANT.

  Patient problems: Injury

  MAUDE report 8409883 ↗

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