JOURNEY 71422424Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556087992), received between Dec 18, 2018 and Sep 6, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2022Failure to Osseointegrate; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Failure to Osseointegrate; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2020 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A ASEPTIC LOOSENING OF THE TIBIAL IMPLANT AND COMPONENT DISSOCIATION OF THE INSERT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 WERE ALL COMPONENTS WHERE EXCHANGE TO COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY THE (B)(6), 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; Joint Dislocation

  MAUDE report 15360153 ↗
• InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2016 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 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: Inadequate Osseointegration

  MAUDE report 15358775 ↗
• InjurySep 5, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2019 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 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 15355898 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE TIBIAL BASEPLATE BECAME LOSE, THE CEMENT WAS STILL ATTACHED TO THE TIBIAL IMPLANT BUT CEMENT FAILED (LOOSENED FROM TIBIAL BONE), IT WAS NOT A S&N CEMENT. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2021, IN WHICH THE ORIGINAL UNI IMPLANTS WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12908606 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SLOW POST-OP RECOVERY DUE TO PAIN.

  Patient problems: Injury

  MAUDE report 8176518 ↗

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