Skip to content

JOURNEY II XR 74023862Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II XR ARTICULAR INSERT XLPE LATERAL SIZE 5-6 LEFT 10MM · Class 2 · Implant

All models of JOURNEY II XR (85)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556615768), received between Jul 23, 2018 and Apr 30, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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

  • Insufficient Device Problem Information3
  • Loss of Osseointegration1

Patient problems

  • Injury4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE ARTHROFIBROSIS. ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

    Patient problems: Injury

    MAUDE report 10013909 ↗
  • InjuryNov 26, 2019Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE ISSUE.

    Patient problems: Injury

    MAUDE report 9378522 ↗
  • InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS OF LEFT KNEE.

    Patient problems: Injury

    MAUDE report 9313361 ↗
  • InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

    Patient problems: Injury

    MAUDE report 7711897 ↗

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