JOURNEY 74025622Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556422663), received between Aug 20, 2018 and Mar 3, 2026 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K121443, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Flaked; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON TWO YEARS AGO ON AN UNKNOWN DATE, THE PATIENT WAS WALKING AROUND IN VALGUS WHICH LIKELY ACCELERATED THE WEAR ON THE POLY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE JRNY II CR ISRT XLPE LT SZ 1-2 10MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24502983 ↗
• InjuryMar 5, 2024Degraded; Biocompatibility; Deformation Due to Compressive Stress; Degraded; Biocompatibility; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, AFTER PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022, THERE WERE NO PROBLEMS 3 MONTHS POSTOPERATIVELY. ON (B)(6) 2024, THERE WAS SIGN OF INFECTION, AND X-RAYS SHOWED ABNORMAL SOFT TISSUE GROWTH AND METALLOSIS. ALL IMPLANTS WERE REMOVED ON (B)(6) 2024. THE JRNY II CR ISRT XLPE LT SZ 1-2 10MM WAS WORN AND DEFORMED. THE JRNY II CR FEM OX NP LT SZ 3 AND JOURNEY TIBIA BASE NP LT SZ 2 WERE ALSO SIGNIFICANTLY WORN DUE TO HIT EACH OTHER. HEATH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection; Metal Related Pathology

  MAUDE report 18842337 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 DUE TO INSTABILITY OF THE IMPLANT IN PATIENT'S LEFT KNEE. THE FEMORAL COMPONENT AND THE INSERT WERE EXPLANTED. THE OUTCOME OF THE EVENT IS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10468826 ↗
• InjuryAug 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A SUBJECT ACQUIRED INSTABILITY OF LEFT TKA. SUBJECT WAS PLACED IN BRACE IN (B)(6) 2018; DETERMINATION MADE IN (B)(6) 2018 TO REVISE INSERT.

  Patient problems: Injury

  MAUDE report 7799483 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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