JOURNEY II XR 74023710Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556612804), received between Nov 20, 2017 and Sep 21, 2021 — 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.

• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED RIGHT KNEE INSTABILITY AND PATELLA SUBLUXATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION OF TIBIAL AND FEMORAL COMPONENTS ON (B)(6) 2019. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Subluxation

  MAUDE report 12511060 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON WASHED THE AFFECTED AREA AND REPLACED THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 7046871 ↗

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