JOURNEY 71422262Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010582218), received between Apr 7, 2019 and Apr 25, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

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

• MalfunctionApr 25, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY UNI TIBINRT S5-6LM/RL9MM WAS NOT LOCKING. THE PROCEDURE WAS RESUMED, AFTER A 20 MINUTE DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812034 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS AHLBÄCK DISEASE SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON AN UNKNOWN DATE DUE TO AN UNSPECIFIED INFECTION WHERE THE TIBIAL INSERT WAS EXCHANGED. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED SEVEN (7) DAYS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED RETROSPECTIVELY; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16546634 ↗
• InjuryDec 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A UNICOMPARTMENTAL KNEE SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED DISPLACEMENT OF THE IMPLANTED JOURNEY UNI TIBIAL INSERT SIZE 5-6 LM/RL 9MM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE INSERT WAS EXCHANGED. IT WAS OBSERVED THAT THE PATIENT COULD NOT REACH MORE THAN 80 DEGREES OF FLEXION DURING REHABILITATION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 16048653 ↗
• InjuryJul 6, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIAL IMPLANT.

  Patient problems: Injury

  MAUDE report 8765809 ↗
• InjuryApr 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION STATUS POST TOTAL KNEE ARTHROPLASTY.

  Patient problems: Unspecified Infection

  MAUDE report 8489977 ↗

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