JOURNEY 74021263Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556615249), received between Jun 18, 2020 and Apr 8, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

• InjuryApr 8, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BILATERAL PATIENT UNDERWENT A PRIMARY TKA ON (B)(6) 2023, THEY DEVELOPED A POSTERIOR DISLOCATION OF THE LEFT KNEE WHEN SLEEPING ON HER SIDE IN FULL FLEXION. DISLOCATION WAS IRREDUCIBLE BY CLOSED MEASURES. THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO EXCHANGE A JRNY II CR FEM COCR NP LT SZ 3 FOR A BCS FEMUR AND UP SIZE THE POLYETHYLENE. PATIENT IS DOING WELL, AND HAD NO FURTHER DISLOCATIONS REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19060871 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA HAD TO BE PERFORMED ON THE LEFT KNEE. IT IS UNKNOWN THE REASON OF THE ADVERSE EVENT. THE PATIENT OUTCOME WAS SUCCESSFULLY RESOLVED. NO INJURY NOR DELAY HAS BEEN REPORTED.

  Patient problems: Injury

  MAUDE report 10166229 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA HAD TO BE PERFORMED ON THE LEFT KNEE. IT IS UNKNOWN THE REASON OF THE ADVERSE EVENT. THE PATIENT OUTCOME WAS SUCCESSFULLY RESOLVED. NO INJURY NOR DELAY HAS BEEN REPORTED.

  Patient problems: Injury

  MAUDE report 10166227 ↗

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