JOURNEY 74021168Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556422755), received between Aug 22, 2018 and Feb 7, 2022 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAS BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED A DEEP VEIN THROMBOSIS. THIS ADVERSE EVENT WAS SOLVED BY MEDICATION. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13476524 ↗
• InjuryOct 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE STIFFNESS AFTER LEFT TKA. PATIENT WAS NOT SHOWING IMPROVEMENT IN RANGE OF MOTION AND UNDERWENT A MANIPULATION UNDER ANESTHESIA TO RESOLVE THE EVENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 10624717 ↗
• InjuryAug 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT MANIPULATION UNDER ANESTHESIA WAS REQUIRED DUE TO STIFFNESS.

  Patient problems: Injury

  MAUDE report 8929065 ↗
• MalfunctionAug 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED RIGHT TIBIAL SPINE FRACTURE AND ACL DEFICIENCY POST OPERATIVE.

  Patient problems: Injury

  MAUDE report 8881970 ↗
• InjuryJul 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT PRESENTING A SWOLLEN KNEE AND BIOPSIES INDICATED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8818604 ↗
• InjuryAug 22, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON CHOSE TO REMOVE THE IMPLANTED XR AND REVISE TO A BCS.

  Patient problems: No Code Available

  MAUDE report 7805018 ↗

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