JOURNEY 74027235Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556179215), received between Dec 19, 2017 and Aug 11, 2024 — classified as 7 injuries.

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.

• InjuryAug 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT FELL AND TORE PART OF HER CAPSULE. ONCE THE CAPSULE WAS OPENED IT WAS NOTED THAT THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 13MM WAS NOT LOCKED INTO THE TIBIA AND THAT THE DOVETAIL ON THE BACK OF THE INSERT WAS DEFORMED. THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 13MM WAS REPLACED FOR A 15MM INSERT. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958106 ↗
• InjuryJul 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER UNDERGOING A TKA ON UNKNOWN DATE, PATIENT'S INSERT WAS NOTICED TO BE UNSTABLE. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 13MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 19768024 ↗
• InjuryApr 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2022, THE PATIENT FELL AND FRACTURED THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 13MM. A REVISION SURGERY WAS REQUIRED AND PERFORMED ON (B)(6) 2022. THE SURGEON SAYS THE DEVICE WAS NOT DEFECTIVE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14146623 ↗
• InjuryOct 15, 2020Adverse 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) 2019, THE PATIENT REQUIRED MANIPULATION UNDER ANESTHESIA FOR AN UNKNOWN REASON.

  Patient problems: No Information

  MAUDE report 10683367 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN IMPLANTED IN (B)(6) 2019, THE PATIENT PRESENTED RECENTLY AN UNSTABLE KNEE. A REVISION SURGERY WAS PERFORMED TO REMOVE BCS POLY; A THICKER CONSTRAINED INSERT WAS FOUND TO BE STABLE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10682646 ↗
• InjuryJul 25, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN WHICH A DISLOCATION OCCURRED WHEN KNEE BENT. THEREFORE, INSERT WAS REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 7720794 ↗
• InjuryDec 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A RIGHT PERIPROSTHETIC FRACTURE. JOURNEY KNEE WAS REPLACED BY A LEGION KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7131126 ↗

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