JOURNEY 74025731Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556097212), received between Dec 4, 2018 and Mar 17, 2020 — classified as 2 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 (K113482, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 9842167 ↗
• InjuryDec 4, 2018Adverse 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 A PATIENT WHO WAS DIAGNOSED WITH CANCER AFTER HIS HIP REPLACEMENT, STARTED SWELLING AFTER HIS 4TH DOSE OF CHEMO AND GOT INFLAMED. THE DR DID A DEBRIDEMENT AND SYNOVECTOMY, CHANGED THE POLY, AND PLACED ANTIBIOTICS INTO THE WOUND BEFORE CLOSING UP AGAIN.

  Patient problems: Injury; Joint Swelling

  MAUDE report 8128359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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