JOURNEY 74027264Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556178119), received between Jan 7, 2020 and Jun 20, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON 2014, THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM POST BROKE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE INSERT WAS EXCHANGED TO A 15MM AS BCS POLY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25570112 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED BACK KNEE AND LOOSED KNEE TENSION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM WAS EXCHANGED TO JOURNEY II BCS INSERT 18MM. THE OTHER IMPLANTS REMAINED IN PATIENT. THE SURGEON DID NOT THINK THE PRODUCTS FAILED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hyperextension; Joint Laxity

  MAUDE report 18670694 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED SWELLING AND INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH WASHING OF KNEE JOINT WAS CONDUCTED. THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM WAS EXCHANGED TO ANOTHER JOURNEY II BCS INSERT. THE FEMORAL COMPONENT, TIBIAL BASEPLATE, AND PATELLA COMPONENT REMAINED IN SITU. THE SURGEON DOES NOT THINK THERE WAS A PRODUCT FAILURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18270751 ↗
• InjuryDec 2, 2021Adverse 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 (B)(6) 2016, THE PATIENT COMPLAINED OF INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 5-6 LEFT 12MM. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12919831 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO AN ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 9711207 ↗
• InjuryJan 7, 2020Unstable; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT BEEN UNSTABLE; A THICKER INSERT WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 9558930 ↗

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