JOURNEY 74025781Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556099216), received between Dec 23, 2021 and Jan 30, 2025 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K113482, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP FOR A TKA SURGERY, WHEN THE BOX WAS OPENED IT WAS NOTICED THAT BOTH OUTER AND INNER POUCH OF A JRNY II ISRT XLPE DD LT SZ 7-8 9MM WERE OPENED IN THE SAME SPOT ON THE SIDE. CONTENTS WERE NOT STERILE AS A RESULT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274191 ↗
• MalfunctionDec 23, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL KNEE ARTHROPLASTY CASE, UPON OPENING THE DEVICES, IT WAS NOTICED THAT THE INNER PACKAGING OF TWO (2) JOURNEY II DEEP DISHED LEFT INSERTS SIZE 7-8 9MM WAS DAMAGED AND ALREADY OPEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078155 ↗
• MalfunctionDec 23, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL KNEE ARTHROPLASTY CASE, UPON OPENING THE DEVICES, IT WAS NOTICED THAT THE INNER PACKAGING OF TWO (2) JOURNEY II DEEP DISHED LEFT INSERTS SIZE 7-8 9MM WAS DAMAGED AND ALREADY OPEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078148 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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