JOURNEY 74027265Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556178164), received between Oct 18, 2017 and Jul 7, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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.

• InjuryJul 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD EFFUSIONS A YEAR AFTER PRIMARY TKA AND A UNSPECIFIED SURGERY WAS PERFORMED AS TREATMENT.

  Patient problems: Injury

  MAUDE report 8766056 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD DIFFICULT REHABILITATION. PATIENT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534357 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER TKA PATIENT HAS ONGOING PAIN AND SWELLING AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8305481 ↗
• InjuryOct 18, 2017Difficult to Insert; Difficult to Insert

  IT WAS REPORTED A DELAY IN SURGERY SINCE THE INSERT COULD NOT BE INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6957283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5