JOURNEY 71422356Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010627421), received between Sep 6, 2017 and Mar 16, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K073175, K081351, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A UKR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT RETURNED FROM AN OVERSEAS FLIGHT AND FELT PRESYNCOPAL AND WITH PAIN IN THE RIGHT CALF. THE PATIENT WAS LATER DIAGNOSED WITH BILATERAL PULMONARY EMBOLI AND EXTENSIVE RIGHT LOWER LEG DVTS. THE PATIENT IS RECOVERING.

  Patient problems: Thromboembolism

  MAUDE report 16558671 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2017 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED UNEXPLAINED PAIN. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE ALL COMPONENTS WHERE EXCHANGE TO COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Pain

  MAUDE report 15354154 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2018 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED UNEXPLAINED PAIN. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 WERE ALL COMPONENTS WHERE EXCHANGE TO COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Pain

  MAUDE report 15354133 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED RIGHT FEMUR SUBCHONDRAL BONE CYST IN THE LATERAL CONDYLE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO SOLVE THIS ADVERSE EVENT. THE (B)(6) WERE EXPLANTED DURING THE REVISION. THE PATIENT IS STILL RECOVERING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s)

  MAUDE report 13111487 ↗
• InjuryJul 29, 2021Adverse 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 WITH JOURNEY UNI ON (B)(6) 2020, THE PATIENT EXPERIENCED A PROGRESSIVE PATELLOFEMORAL ARTHRITIS. THIS EVENT WAS SOLVED BY A REVISION SURGERY, EXPLANTING THE JOURNEY UNI AND IMPLANTING THE GENESIS, ON (B)(6) 2021. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Arthritis

  MAUDE report 12250745 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO PAIN, FEVER, SWELLING, MIGRATION AND LOOSENING OF TIBIAL BASE PLATE. THE DOCTOR SAYS THE DEVICES WERE NOT DEFECTIVE. THIS WAS CAUSED BY HIGH WEIGHT OF THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Swelling; Pain

  MAUDE report 10259746 ↗
• InjurySep 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A LOOSE TIBIAL INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6844519 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073175, K081351, 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