JOURNEY 74024829Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010554529), received between Mar 14, 2018 and Mar 27, 2019 — classified as 5 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 (K042515, K091014, 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.

• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED IN A STUDY THAT THE PATIENT HAD CELLULITIS AS A RESULT OF LYMPHANGITIS OVER THE ANTEROLATERAL ASPECT OF THE PROXIMAL TIBIA. THE KNEE WAS REPORTED AS WARM AND HYPERSENSITIVE; PATIENT ADMITTED TO HOSPITAL FOR IV ANTIBIOTIC REGIME TO TREAT. THE EVENT WAS ASSESSED BY THE REPORTER AS RELATED TO THE STUDY PROCEDURE AND THE POSSIBILITY OF THE DEVICE CAUSING OR CONTRIBUTING TO THE EVENT COULD NOT BE EXCLUDED.

  Patient problems: Unspecified Infection

  MAUDE report 8457047 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HAVING KNEE PAIN, REDNESS AND SWELLING, AND AN INCISION AND DRAINAGE OF THE LEFT KNEE WITH ARTHROCENTESIS WAS PERFORMED DUE TO PROXIMAL LEG ABCESS WITH SECONDARY CELLULITIS ADJACENT TO TOTAL KNEE ARTHROPLASTY.

  Patient problems: Pain; Swelling

  MAUDE report 8350754 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A COMPLETE SYNOVECTOMY WAS PERFORMED DUE TO AN HEMATOGENOUSLY SPREAD ACUTE DEEP SEPSIS AND ALL TOTAL KNEE IMPLANTS WERE REPLACED WITH IMPLANTATION OF ANTIBIOTIC IMPREGNATED SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8348739 ↗
• InjuryFeb 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  A REVISION SURGERY WAS PERFORMED DUE TO BASEPLATE HAD SUBSIDED AND BONE HAD FORMED AROUND IT. IT WAS REMOVED VIA FLEXIBLE OSTETOME AND PUNCH. FEMUR WAS REMOVED VIA GIGLI SAW AND FLEXIBLE OSTETOME. TIBIA, TEAMED TO 15 X 120, 4MM OFFSET USED, SIZE 3 BASEPLATE. ALL VIA STANDARD TECHNIQUE. TRIALLED. FEMUR, REAMED TO 15 X 160, SIZE 3. ALL VIA STANDARD TECHNIQUE. TRIALLED IMPLANTS WERE CEMENTED IN, 18MM CONSTRAINED TRIAL AND KNEE BALANCED AND THEN INSERTED. WOUND CLOSED.

  Patient problems: Injury

  MAUDE report 8334196 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED FOR ARTHROSCOPIC ABRASION OF CICATRIX..

  Patient problems: Injury

  MAUDE report 7338801 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, 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
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112
• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7