JOURNEY 71422425Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556088043), received between Jul 26, 2018 and Sep 8, 2022 — classified as 6 injuries.

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 (K102069, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2021 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE ALL COMPONENTS WHERE EXCHANGE. 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: Inadequate Osseointegration

  MAUDE report 15385563 ↗
• InjurySep 7, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT UKA SURGERY PERFORMED IN (B)(6) 2014, PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT . THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXCHANGE THE FEMORAL AND TIBIAL COMPONENTS AND THE INSERT. PATIENT HEALTH STATUS IS NOT KNOWN. 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: Inadequate Osseointegration

  MAUDE report 15375200 ↗
• InjuryApr 4, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Material Deformation; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, WITH A UNI JOURNEY SYSTEM, THE PATIENT EXPERIENCED PAIN. X-RAYS INDICATED THAT THE JOURNEY UNI TIBINRT S5-6LM/RL8MM WAS NOT IN ITS POSITION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JRNY UNI TIBIAL BASE LM/RL SZ 5 WAS REMOVED. THE PATIENT'S HEALTH STATUS IS STABLE.

  Patient problems: Implant Pain; Joint Dislocation; Pain

  MAUDE report 13996089 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD PATIENT HAD A JOURNEY UNI IMPLANTED (B)(6) 2019. THE PATIENT RECENTLY WALKING IN BUSH, STUMBLED AND KNEE FELT DIFFERENT. PATIENT HAD LOOSENING OF TIBIAL COMPONENT. AFTER REMOVAL OF COMPONENT, SURGEON FELT THERE WAS A HEALED FRACTURE AROUND THE MEDIAL CORTEX OF TIBIA. REMOVED TIBIAL COMPONENT, AND CEMENTED NEW COMPONENT IN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10356985 ↗
• InjuryApr 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION STATUS POST TOTAL KNEE ARTHROPLASTY.

  Patient problems: Unspecified Infection

  MAUDE report 8489981 ↗
• InjuryJul 26, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY ON LEFT KNEE WAS PERFORMED DUE TO PAIN AND SWELLING. PATIENT WAS TREATED WITH A JOINT INJECTION ON (B)(6) 2018. SINCE THE ISSUE WASN'T RESOLVED WITH THE INJECTION, DR DECIDED TO PERFORM A SURGICAL PROCEDURE ON (B)(6) 2018 TO REMOVE THE PARTS.

  Patient problems: Pain; Swelling

  MAUDE report 7724632 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102069, 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