JOURNEY 71422355Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010627414), received between Jun 19, 2018 and Aug 25, 2023 — classified as 7 injuries, 1 malfunction.

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 (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING TKA SURGERY, WHEN CEMENTING THE DEFINITIVE JUNI OX FB FEM SZ 5 RM LL ONTO THE FEMUR IMPACTED AS PER THE SURGICAL TECHNIQUE AND THE IMPLANT INSTANTLY 'PEELS' AWAY FROM THE BONE ANTERIORLY. THE SAME CEMENT IS USED FOR ALL PRIMARY JOINTS AND NO OTHER PRODUCT HAS THIS ISSUE. SURGEON STATES THE IMPLANT DESIGN THE ANTERIOR PEG APPEARS TO BE TOO SHORT. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627121 ↗
• 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) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED INFECTION. 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: Unspecified Infection

  MAUDE report 15355856 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2018 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 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: Insufficient Information

  MAUDE report 15355833 ↗
• 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 AN UNSPECIFIED ISSUE. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 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: Insufficient Information

  MAUDE report 15355764 ↗
• InjurySep 5, 2022Migration; Migration

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2013 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED DISLOCATION, INSTABILITY AND PROGRESSIVE ARTHRITIS THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017. ALL COMPONENTS WERE EXPLANTED. 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: Joint Dislocation; Joint Laxity

  MAUDE report 15354159 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT FIVE WEEK AFTER PRIMARY, PROSTHESIS WAS EXPLANTED. DETAILS FOR REVISION SURGERY UNSPECIFIED. AN ALTERNATIVE PROSTHESIS WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8364032 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE UNI IMPLANTS FAILED AS PER SURGEON DR. (B)(6). REVISION SURGERY PERFORMED TO EXPLANT DEVICES. UNABLE TO SEE LOTS DUE TO BONE INGROWTH.

  Patient problems: Injury

  MAUDE report 7971313 ↗
• InjuryJun 19, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY REACHING FULL EXTENSION/FLEXION. AN INTERVENTION OF MANIPULATION UNDER ANESTHESIA WAS PERFORMED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7614161 ↗

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