JOURNEY 74027211Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556178669), received between Jun 18, 2018 and May 28, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 9MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25317493 ↗
• InjuryAug 24, 2023Adverse 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) 2023, THE PATIENT EXPERIENCED FEVER AND SUSPECTED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 1-2 RIGHT 9MM WAS EXCHANGED TO ANOTHER JOURNEY II BCS INSERT. THE FEMORAL COMPONENT AND TIBIAL BASEPLATE REMAINED IN SITU. THE SURGEON DID NOT CONSIDER THIS AS A PRODUCT FAILURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 17616470 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED SYNOVITIS AND A SUSPECTED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND WHERE A SYNOVECTOMY WAS PERFORMED AND THE INSERT WAS EXCHANGED. FURTHER MEDICAL INFORMATION IS UNKNOWN AND UNAVAILABLE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15358706 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A KNEE SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED JOINT LAXITY THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021. A JRNY II BCS XLPE ART ISRT SZ 1-2 RT 9MM WAS EXPLANTED. IN ADDITION, A JRNY II BCS CNSTRD ART ISRT 1-2 RT 13M AND A JRNY BCS PAT RESRF RD 29 MM STD WERE IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 11860339 ↗
• MalfunctionMay 13, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA, THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 9MM ((B)(4)) COULD NOT BE INSERTED WITH THE JOURNEY ART ISRT ASSM TOOL ((B)(4)). INSTRUMENT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING BOTH S+N BACK-UP DEVICES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821437 ↗
• InjuryApr 13, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING JOURNEY 2 LEFT TOTAL KNEE CASE AN INCORRECT INSERT (RIGHT J2 BCS) WAS IMPLANTED IN THE PATIENT. THE ERROR WAS DISCOVERED AFTER THE PATIENT HAD ALREADY BEEN CLOSED AND TAKEN TO RECOVERY. THE SURGEON WAS ABLE TO GO BACK IN LATER THE SAME DAY AS THE CASE TO REPLACE THE INCORRECT INSERT WITH THE CORRECT ONE.

  Patient problems: Injury

  MAUDE report 9952949 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION; JOURNEY II BCS INSERT WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 9590557 ↗
• InjurySep 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE INSERT WAS REPLACED TO 15MM INSERT. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9104414 ↗
• InjuryJun 18, 2018Fracture; Fracture

  THE PATIENT HAD THE FEMORAL BONE FRACTURE DUE TO A FALL. THE PATIENT NEEDED TO REVISE THE INSERT TO TREAT WITH THE NAIL. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE. THE PRODUCTS WERE DISPOSED AFTER THE SURGERY, SO IT CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7611887 ↗

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