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JOURNEY II XR 74023831Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II XR ARTICULAR INSERT XLPE LATERAL SIZE 3-4 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
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556615614), received between Jun 6, 2019 and Apr 21, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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

  • Physical Resistance/Sticking2
  • Break1
  • Insufficient Device Problem Information1
  • Patient Device Interaction Problem1

Patient problems

  • Injury4
  • Pain1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED STIFFNESS OF THE RIGHT KNEE FOLLOWING SURGERY. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA. THE OUTCOME OF THE EVENT IS CONSIDERED UNKNOWN.

    Patient problems: Injury

    MAUDE report 9983780 ↗
  • InjuryJun 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT A PATIENT HAD AN ARTHROSCOPY DUE TO PERSISTENT CLUNKING AND POPPING.

    Patient problems: Injury

    MAUDE report 8746877 ↗
  • InjuryJun 30, 2019Break; Break

    IT WAS REPORTED THAT THE PATIENT PRESENTED INTRA-OP MEDIAL TIBIAL PLATEAU FRACTURE WITH ORIF AND SUBSEQUENT HARDWARE REMOVAL DUE TO PERSISTENT PAIN. ADVERSE EVENT WAS RESOLVED.

    Patient problems: Pain

    MAUDE report 8746863 ↗
  • InjuryJun 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT RIGHT KNEE STIFFNESS WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

    Patient problems: Injury

    MAUDE report 8746775 ↗
  • InjuryJun 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT AFTER 6 WEEKS POST OP, PATIENT STILL DID NOT HAVE FULL FLEXION AND DECIDED TO PROCEED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

    Patient problems: Injury

    MAUDE report 8676613 ↗

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