JOURNEY 74025762Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556098462), received between Jul 6, 2017 and Sep 12, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAINFUL S/P TOTAL KNEE. THE PATELLA WAS UNRESURFACED AT THE ORIGINAL PROCEDURE AND WAS SEVERE GRADE IV ARTHRITIS WITH LARGE OSTEOPHYTES AROUND THE INSERT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE JRNY II ISRT XLPE DD LT SZ 5-6 10MM WAS EXCHANGED. THERE WAS NOTHING WRONG WITH THE POLY, EXCEPT IT NEEDED TO BE REMOVED TO DEBRID THE KNEE AND A NEW ONE OF THE SAME SIZE AND THICKNESS WAS USED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17730574 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION KNEE SURGERY WAS PERFORMED DUE TO INFECTION. THE POLY INSERT WAS EXCHANGED DURING THE PROCEDURE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6690226 ↗

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