JOURNEY 74027213Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556178768), received between Mar 30, 2017 and Dec 27, 2024 — classified as 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COUPLE OF YEARS AFTER A TKA SURGERY WAS PERFORMED, ON AN UNKNOWN DATE, THE PATIENT STARTED EXPERIENCING HYPEREXTENSION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT, BY SWAPPING THE POLY TO A 18MM BCS INSTEAD. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Hyperextension

  MAUDE report 21031348 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED PAIN DURING REHABILITATION. THE X RAY SHOWED THAT THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM WAS DISASSOCIATED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS EXCHANGED. THE DOCTOR THINKS THAT THIS WAS DUE TO INADEQUATE INSERTION OF THE INSERT. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 19116311 ↗
• InjuryJan 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023 THE PATIENT EXPERIENCED A LOOSE FROM THE TIBIAL BASEPLATE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023 WHERE THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM WAS EXCHANGED AND A NEW 12MM 1-2 RIGHT JOURNEY LL POLY WAS PUT IN. PATIENT WAS STABLE.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 18527109 ↗
• InjuryJun 22, 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 EXPERIENCED RIGHT KNEE PAIN AND INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY REMOVING THE JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3 ((B)(4)) AND THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM ((B)(4)) ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 12046542 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED DUE TO INFECTION. THE DOCTOR SAYS THE DEVICES WERE NOT DEFECTIVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11479233 ↗
• MalfunctionApr 3, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, THE INSERT CANNOT BE INSERTED FULLY ONTO THE BASEPLATE. THE INSERT WAS SLIDING ONTO THE BASEPLATE, A RESISTANCE WAS FELT BY THE SURGEON AND IT DIDN'T FEEL SMOOTH, THE ANTERIOR SIDE OF THE INSERT WAS NOT SAT FULLY ONTO THE BASEPLATE, ALSO IT WAS NOT FIT OR LOCKED. IT CAUSED 10 MINUTES DELAY OF SURGERY. AN ALTERNATIVE DEVICE, S&N 12MM INSERT, WAS USED TO FINISH THE SURGERY. NO INJURY REPORTED NOR ADDITIONAL BONE CUTS WERE REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9921364 ↗
• InjuryMar 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND PYREXIA. THE SURGEON DECIDED IT IS NOT PRODUCT FAILURE BECAUSE IT OCCURRED AFTER A LONG TIME SINCE THE PRIMARY SURGERY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6448175 ↗

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