JOURNEY 74025642Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556422526), received between Jun 17, 2019 and Nov 5, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STITCH ABCESS IN THE DISTAL END OF HER LEFT KNEE INCISION. IT WAS TREATED WITH ANTIBIOTICS AND SURGERY FOR INCISION AND DRAINAGE. THE WOUND HAD DELAYED HEALING WITH CONTINUED ANTIBIOTICS AND BETADINE TREATMENTS.

  Patient problems: Injury

  MAUDE report 9281432 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO ARTHROFIBROSIS ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8867903 ↗
• InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED A FALL. AN UNSPECIFIED SURGICAL PROCEDURE WAS PERFORMED DUE TO LEFT KNEE ARTHROFIBROSIS. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 8739746 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8704615 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH MEDICATION AND CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8704612 ↗

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