JOURNEY 74025771Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556098813), received between Sep 22, 2022 and Apr 3, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE STERILE PACKAGE OF A JRNY II ISRT XLPE DD RT SZ 7-8 9MM WAS OPENED IN THE SEALED BOX. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034350 ↗
• MalfunctionMay 30, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT THE STERILE PACK OF ONE (1) JRNY II ISRT XLPE DD RT SZ 7-8 9MM WAS NOT SEALED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022552 ↗
• InjurySep 22, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, WHILE PERFORMING A TKA REVISION SURGERY ON (B)(6) 2022, IT WAS FOUND THAT THE INNER PEEL PACK OF THE JRNY II ISRT XLPE DD RT SZ 7 8 9MM WAS OPENED. SINCE THERE WERE NO MORE IMPLANTS AVAILABLE, SURGEON HAD TO CLOSE THE KNEE, AFTER A SIGNIFICANT DELAY, WITH A TRIAL IN AND RESCHEDULED THE CASE FOR THE NEXT DAY. THE FOLLOWING DAY, ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED IN ORDER TO IMPLANT A NEW STERILE INSERT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467203 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN ACUTE INFECTION. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A CLEAN OUT WAS PERFORMED, AS WELL AS A POLY SWAP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 15467126 ↗
• InjurySep 22, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, WHILE PERFORMING A TKA REVISION SURGERY ON (B)(6) 2022, IT WAS FOUND THAT THE INNER PEEL PACK OF THE JRNY II ISRT XLPE DD RT SZ 7 8 9MM WAS OPENED. SINCE THERE WERE NO MORE IMPLANTS AVAILABLE, SURGEON HAD TO CLOSE THE KNEE, AFTER A SIGNIFICANT DELAY, WITH A TRIAL IN AND RESCHEDULED THE CASE FOR THE NEXT DAY. THE FOLLOWING DAY, ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED IN ORDER TO IMPLANT A NEW STERILE INSERT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466885 ↗

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