JOURNEY 74029263Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556176511), received between May 19, 2021 and Aug 5, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K140555, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED LOOSENING OF THE JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M IMPLANT, AND FALLING. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH THE JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M DID NOT SEEMED TO BE DEFECTIVE, BUT IT WAS EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Laxity

  MAUDE report 12285304 ↗
• InjuryJun 2, 2021Adverse 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 EXPERIENCE DISLOCATION THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021. A JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M WAS REPLACED. THE PATIENT OUTCOME IS UNKNOWN, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 11922102 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND SWELLING FROM INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M WAS EXPLANTED AND A WASHOUT PROCEDURE PERFORMED. THE DEVICE EXPLANTED WAS REPLACED WITH A JRNY II BCS CNSTRD ART ISRT 5-6 LT 13M. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Pain; Unspecified Infection

  MAUDE report 11894199 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND SWELLING FROM INFECTION. A PREVIOUS WASHOUT AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2021. AFTER THIS PROCEDURE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE JRNY II BCS CNSTRD ART ISRT 5-6 LT 13M WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555, 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