JOURNEY II XR 74022202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556615324), received between Jan 30, 2019 and Apr 13, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ANTERIOR CRUCIATE LIGAMENT RUPTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT ON WHICH THE TIBIAL COMPONENT WAS REPLACED. PATIENT'S OUTCOME IS PENDING.

  Patient problems: Rupture

  MAUDE report 16732358 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORM DUE TO A FEELING WRONGNESS. S+N DEVICES WERE NOT DEFECTIVE. IT IS UNKNOWN HOW IS THE STATUS OF THE PATIENT.

  Patient problems: Discomfort; Injury

  MAUDE report 10513872 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED PATELLAR IMPINGEMENT ON LEFT KNEE. EVENT WAS TREATED WITH AN ARTHROSCOPIC SYNOVECTOMY.

  Patient problems: Injury

  MAUDE report 10014890 ↗
• InjuryJan 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LEFT KNEE ACL/BRIDGE LOOSENING. EVENT TREATED WITH CANNULATED SCREW FIXATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 8288397 ↗

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