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JOURNEY II XR 74023742Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II XR ARTICULAR INSERT XLPE MEDIAL SIZE 3-4 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
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556612859), received between Jul 24, 2019 and Apr 24, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 Information2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Injury2
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED LEFT KNEE HEMARTHROSIS AND CELLULITIS. THE EVENT WAS RESOLVED VIA REVISION SURGERY. THE EVENT IS CONSIDERED ONGOING.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 9997802 ↗
  • InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SCAR TISSUE DEBRIDEMENT ON THE LEFT KNEE. THE EVENT WAS TREATED VIA ARTHROSCOPY AND WAS RESOLVED WITH RESIDUAL EFFECTS.

    Patient problems: Injury

    MAUDE report 9901047 ↗
  • InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND LIMITED RANGE OF MOTION. NO MORE INFORMATION PROVIDED YET.

    Patient problems: Pain

    MAUDE report 8824868 ↗

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