JOURNEY 74021159Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556531914), received between Mar 30, 2020 and Nov 2, 2020 — classified as 4 injuries.

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

• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE, IN WHICH A JOURNEY II CR FEM OXINIUM NP RIGHT SIZE 9 WAS USED, THE PATIENT PRESENTED A RIGHT QUADRICEPS TENDON RUPTURE. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 10775207 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICAL SUBJECT EXPERIENCED A FALL AND DEVELOPED CELLULITIS AS A RESULT OF IT. THE PATIENT UNDERWENT AN ASPIRATION WHICH DETERMINED THERE WAS PRESENCE OF A RIGHT KNEE INFECTION. THE EVENT WAS TREATED VIA REVISION SURGERY TO REMOVE THE AFFECTED COMPONENTS.

  Patient problems: Cellulitis; Injury; Unspecified Infection

  MAUDE report 10604543 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE EFFUSION AND HEMARTHROSIS. THE EVENT WAS TREATED VIA ABLATION AND ARTHROSCOPY.

  Patient problems: Injury

  MAUDE report 9900929 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9900915 ↗

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