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JOURNEY 71422256Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY UNI TIBIA INSERT SIZE 3-4RIGHT MEDIAL/LEFT LATERAL 9MM · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010582171), received between Dec 18, 2018 and May 5, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K061011, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Connection Problem1
  • Difficult to Insert1
  • Incomplete or Inadequate Connection1
  • Insufficient Device Problem Information1

Patient problems

  • Injury1
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 5, 2021Difficult to Insert; Incomplete or Inadequate Connection; Difficult to Insert; Incomplete or Inadequate Connection

    IT WAS REPORTED THAT DURING UKR THE JOURNEY UNI TIBINRT S3-4RM/LL9MM DID NOT CLICK IN THE SIZE 4 TRAY. NO SIGNIFICANT DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURIES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11780669 ↗
  • InjurySep 10, 2020Connection Problem; Connection Problem

    IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS UNABLE TO SEAT THE POLY LINER AND HAD TO REMOVE IT. THE LINER WAS DAMAGED IN THE PROCESS OF REMOVING. A BACK UP DEVICE WAS AVAILABLE AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. A FIVE MINUTE DELAY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10518678 ↗
  • InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED A SLOW POST-OP RECOVERY DUE TO PAIN.

    Patient problems: Injury

    MAUDE report 8176806 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061011, 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, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.