JOURNEY II XR 74022207Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556615379), received between Sep 5, 2019 and May 15, 2023 — 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 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT BICRUCIATE RETAINING TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT DEVELOPED PAIN AND INSTABILITY. THIS WAS TREATED ON (B)(6) 2022 BY PERFORMING A REVISION SURGERY, WHERE IT WAS DETERMINED THAT THE PATIENT HAD AN ANTERIOR CRUCIATE LIGAMENT (ACL) RUPTURE. THE SURGEON DECIDED TO KEEP THE FEMORAL AND PATELLAR COMPONENTS AND ONLY REVISE THE TIBIAL COMPONENT AND THE INSERTS. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. PATIENT HAS STATED THAT IS STILL HAVING ISSUES WITH THE KNEE.

  Patient problems: Damage to Ligament(s); Insufficient Information

  MAUDE report 16935011 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH BETADINE AND ANTIBIOTIC DUE TO A SUTURE REACTION. THE EVENT WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 8967380 ↗

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