JOURNEY 71422436Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556088395), received between Oct 16, 2018 and Jun 29, 2021 — classified as 6 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 (K102069, 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF A JOURNEY UNI KNEE TIBIAL INSERT WAS PERFORMED. PRIMARY IMPLANTATION WAS PERFORMED ON (B)(6) 2016. DURING THE REVISION WAS IDENTIFIED THAT THERE WAS AN UNUSUAL EARLY COMPLETE WEAR OF THE INSERT, ALSO THERE WAS MASSIVE METALLOSIS AND PRONOUNCED SOFT TISSUE DAMAGE. TIBIAL BASEPLATE AND FEMORAL COMPONENT WERE ALSO EXPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology; Unspecified Tissue Injury

  MAUDE report 12086074 ↗
• InjuryApr 23, 2021Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A NAVIO ASSISTED UNICONDYLAR KNEE REPLACEMENT, THE PATIENT COLLAPSED INTO VALGUS. IMPLANTS WERE REVISED TO A LEGION HINGE WITH CONES AND STEMS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11720857 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE REPLACEMENT ON (B)(6) 2018, WHERE HE HAD A BARING LOCKING MECHANISM FITTED. SHORTLY AFTER THE SURGERY THE BARING LOCKING MECHANISM FAILED CAUSING THE CLAIMANT TO SUFFER FROM SEVERE PAIN. THIS REQUIRED THE PATIENT TO UNDERGO A SECOND SURGERY ON (B)(6) 2018 WHICH FAILED AGAIN, AND A THIRD OPERATION WAS REQUIRED ON (B)(6) 2018. THE INSERT, TIBIAL AND FEMORAL COMPONENTS WERE REMOVED AND COMPETITOR DEVICES WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 8660272 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FIVE WEEK AFTER PRIMARY, PROSTHESIS WAS EXPLANTED. DETAILS FOR REVISION SURGERY UNSPECIFIED. AN ALTERNATIVE PROSTHESIS WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8362535 ↗
• InjuryNov 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT MALFUNCTION. INSERT AND TIBIAL TRAY EXPLANTED. BACK UP AVAILABLE.

  Patient problems: Injury

  MAUDE report 8030410 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE UNI IMPLANTS FAILED AS PER SURGEON DR. (B)(6). REVISION SURGERY PERFORMED TO EXPLANT DEVICES.

  Patient problems: Injury

  MAUDE report 7970329 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102069, 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