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JOURNEY II XR 74023762Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II XR ARTICULAR INSERT XLPE MEDIAL 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 00885556612903), 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
  • Adverse Event Without Identified Device or Use Problem1

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 10013851 ↗
  • InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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 9378408 ↗
  • 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 9313368 ↗
  • 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 7712409 ↗

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

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