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JOURNEY II XR 74023851Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II XR ARTICULAR INSERT XLPE LATERAL SIZE 5-6 RIGHT 9MM · Class 2 · Implant

All models of JOURNEY II XR (85)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556615706), received between Jul 19, 2018 and May 4, 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Arthralgia1
  • Inflammation1
  • Loss of Range of Motion1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY IN WHICH A JOURNEY II XR LATERAL INSERT WAS IMPLANTED, THE CLINICAL SUBJECT PRESENTED POST-OPERATIVE STIFFNESS AND PAIN. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT HAS RECOVERED.

    Patient problems: Arthralgia; Loss of Range of Motion

    MAUDE report 10021212 ↗
  • InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT DUE TO RIGHT KNEE INFLAMMATION THE PATIENT HAS BEEN GIVEN MEDICATIONS SUCH AS VICODIN AND PREDNISONE.

    Patient problems: Inflammation

    MAUDE report 7705311 ↗

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

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page