JOURNEY II XR 74023731Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556613078), received between Jun 30, 2019 and Dec 23, 2020 — 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.

• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRIMARY JOURNEY XR KNEE REPLACEMENT WAS DONE BY ANOTHER SURGEON IN (B)(6) 2020. THEN, THE PATIENT WAS REVISED ON (B)(6) BECAUSE THE PATIENT COMPLAINED OF KNEE PAIN AND COULD NOT FLEX THE KNEE PAST 95 DEGREES AFTER THE INITIAL OPERATION. THE SURGEONS IDENTIFIED THAT THE PROBLEM WAS BECAUSE THE JOINT LINE WAS RAISED BY ABOUT 10 MM AND THE TIBIAL SLOPE WAS DECREASED FROM ABOUT 10 DEGREES TO ZERO.

  Patient problems: Pain

  MAUDE report 11069645 ↗
• InjuryJun 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED INTRA-OP MEDIAL TIBIAL PLATEAU FRACTURE WITH ORIF AND SUBSEQUENT HARDWARE REMOVAL DUE TO PERSISTENT PAIN. ADVERSE EVENT WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 8746859 ↗

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