JOURNEY 74027273Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556179819), received between Feb 28, 2018 and Apr 29, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A CLINICAL TRIAL, AFTER A TKA PERFORMED ON (B)(6) 2014, SINCE (B)(6) 2015 THE PATIENT PRESENTED MILD PAIN ON THE LATERAL SIDE OF THE KNEE, ON (B)(6) 2022 INSTABILITY WAS REPORTED. THIS ADVERSE EVENT WAS RESOLVED BY REVISION SURGERY ON (B)(6) 2023, TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 11MM. BY (B)(6) 2023 THE PATIENT WAS RECOVERED.

  Patient problems: Joint Laxity

  MAUDE report 21926791 ↗
• InjuryAug 15, 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 IN (B)(6) 2014, THE PATIENT STATED HE WAS SQUATTING AND HEARD A SNAP. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY TO SWAP THE POLY ON (B)(6) 2023 TO CORRECT THE INSTABILITY. THE PATIENT LEFT THE SURGERY IN GOOD HEALTH.

  Patient problems: Joint Laxity

  MAUDE report 17553608 ↗
• InjuryJun 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY WAS PERFORMED ON THE (B)(6) 2014, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 DUE TO A BROKEN POST OF THE ARTICULAR INSERT. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 17242533 ↗
• InjuryNov 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2016 THE POST OF A JRNY II BCS XLPE ART ISRT SZ 7-8 RT 11MM BROKE DUE TO UNKOWN REASONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE THE BROKEN INSERT WITH A 12MM DEEP DISH. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 15777619 ↗
• InjuryMar 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS REQUIRED TO CHANGE A JOURNEY II BCS XLPE ART INSERT SIZE 7-8 RT 11MM DUE TO MECHANICAL FAILURE. THE PATIENT SUFFERED A RUPTURE OF THE RETINACULAR MECHANISM. THE OLD POLY WAS EXCHANGED BY A JOURNEY II CONSTRAINED INSERT. NO OTHER COMPLICATIONS WERE REPORTED. NO PATIENT INFORMATION OR OPERATIVE REPORTS ARE AVAILABLE. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Muscle/Tendon Damage

  MAUDE report 11427093 ↗
• InjuryMar 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PATIENT DISLOCATED PROSTHESIS.

  Patient problems: Injury

  MAUDE report 7307525 ↗
• InjuryFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE ASPIRATION WAS PERFORMED DUE TO SWELLING OF RIGHT KNEE .

  Patient problems: Joint Swelling

  MAUDE report 7302665 ↗

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