JOURNEY II XR 74023712Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556612972), received between Feb 5, 2019 and May 31, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152726, 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.

• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14548264 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. BASEPLATE AND INSERT WERE REMOVED. OSTEOPOROTIC PATIENT SUSPECTED.

  Patient problems: Injury

  MAUDE report 8305994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152726, 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