JOURNEY 74025641Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556422533), received between Jul 28, 2019 and Feb 26, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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.

• MalfunctionFeb 26, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PRISTINE OUTER PACKING OF THE JRNY II CR ISRT XLPE LT SZ 3-4 9MM WAS OPENED UP AND THE INNER PACKAGE HAD A HOLE, AS THE INSERT WAS LOOSE IN THE BOX. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777417 ↗
• InjuryApr 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14040885 ↗
• MalfunctionDec 1, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF TWO (2) JOURNEY II CR INSERT XLPE LEFT SIZE 3-4 9MM, INTENDED TO BE USED ON A TKA, WERE OPENED INSIDE A SEALED BOX, EACH IN IT'S OWN BOX. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908928 ↗
• MalfunctionDec 1, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF TWO (2) JOURNEY II CR INSERT XLPE LEFT SIZE 3-4 9MM, INTENDED TO BE USED ON A TKA, WERE OPENED INSIDE A SEALED BOX, EACH IN IT'S OWN BOX. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908911 ↗
• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE CLINICAL SUBJECT EXPERIENCED ASEPTIC LOOSENING OF KNEE PROSTHESIS THAT ENDED UP BEEN TREATED WITH A LEFT KNEE REVISION SURGERY ON (B)(6) 2020. THE ISSUE WAS RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 11907591 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: JOURNEY II CR RETRO: IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS ON THE LEFT KNEE, IT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. THE OUTCOME IS RESOLVED. REHABILITATION WAS PRESCRIBED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Fibrosis

  MAUDE report 10365743 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8868009 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8867684 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WHICH WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Fibrosis

  MAUDE report 8834723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, K230653. One submission often covers many models, so check the product and lot details in each record.

• 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