JOURNEY 74024838Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010554550), received between Apr 24, 2017 and May 18, 2020 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT DEVELOPED AN INFECTION. THE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY: THE JOURNEY II RESURFACED PATELLAR COMPONENT WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10065232 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8868022 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND THIS CAUSED A RUPTURED PATELLAR TENDON, THIS WAS SURGICALLY CORRECTED.

  Patient problems: Injury

  MAUDE report 8867740 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATELLA PEGS WERE FAILING. SURGEON REVISED THE PATELLA.

  Patient problems: Injury

  MAUDE report 8492025 ↗
• InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER UNDERWENT A TOTAL KNEE ARTHROPLASTY FOR A STUDY, THE PATIENT HAD DELAYED WOUND HEALING AND POSSIBLE INFECTION. REVISION SURGERY AND DRAINAGE WERE PERFORMED WITH A POLY EXCHANGE. THE SUBJECT RECOVERED FROM THE EVENT BUT WAS TERMINATED FROM THE STUDY. THE EXPLANTED DEVICE WAS DESTROYED.

  Patient problems: Unspecified Infection

  MAUDE report 8434683 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS IN THE RIGHT KNEE. EVENT TREATMENT INCLUDED SURGERY/PROCEDURE.

  Patient problems: Injury

  MAUDE report 7807670 ↗
• InjuryJul 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT KNEE EFFUSION WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7714977 ↗
• InjuryJul 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DUE TO RIGHT KNEE INFLAMMATION THE PATIENT HAS BEEN GIVEN MEDICATIONS SUCH AS VICODIN AND PREDNISONE.

  Patient problems: Inflammation

  MAUDE report 7707411 ↗
• InjuryApr 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED RIGHT KNEE ARTHROFIBROSIS. A MANIPULATION UNDER ANESTHESIA WAS DONE.

  Patient problems: Injury

  MAUDE report 7471169 ↗
• InjuryApr 2, 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 EXCISION OF HYPERTROPHIC SCAR.

  Patient problems: Pain

  MAUDE report 7389877 ↗
• InjuryFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE ASPIRATION WAS PERFORMED DUE TO SWELLING OF RIGHT KNEE.

  Patient problems: Joint Swelling

  MAUDE report 7302666 ↗
• InjurySep 1, 2017Failure To Adhere Or Bond; Noise, Audible

  IT WAS REPORTED THAT PATIENT WAS STEPPING BACKWARDS DOWN A STEP AND HEARD A"POPPING" SENSATION AND IMMEDIATE PAIN. REVISION SURGERY WAS DONE DUE TO PATELLAR FRACTURE AND LOOSENING OF PATELLAR COMPONENT WITH REVISION OF PATELLAR COMPONENT AND TIBIAL INSERT.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 6838196 ↗
• InjuryApr 24, 2017Insufficient Device Problem Information

  IT WAS REPORTED THROUGH CLINICAL STUDY THAT PATIENT UNDERWENT "OTHER CONSERVATIVE APPROACH" IN ORDER TO ADDRESS PRE-PATELLAR EFFUSION. OUTCOME WAS DEEEMED RESOLVED ON THE SAME DAY AND SEVERITY DEEMED AS MODERATE.

  Patient problems: Joint Swelling; No Code Available; Pain

  MAUDE report 6515171 ↗

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-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-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-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