JOURNEY 71422423Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556087947), received between Feb 12, 2019 and Dec 20, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryDec 20, 2022Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A CORI ASSISTED JOURNEY UKA SURGERY WAS PERFORMED ON THE (B)(6) 2022, THE PATIENT PRESENTED TO THE PRACTICE ON THE (B)(6) 2022 DUE TO A SQUEAKING IN THE KNEE. A DIAGNOSIS FOLLOWED AND THE X-RAY FINDINGS WERE CLEAR FOR REVISION, WHICH WAS PERFORMED ON THE (B)(6) 2022. DURING THE REVISION, SEVERE METALLOSIS WAS FOUND AND THE INLAY WAS NOT ANCHORED IN THE TIBIAL PLATEAU; THE TIBIA WAS LOOSE. THE REVISION WAS EXTENSIVE WITH SOFT TISSUE REMOVAL. A LEGION SYSTEM WAS IMPLANTED INSTEAD. THE PATIENT STATUS IS GOOD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Discomfort; Inadequate Osseointegration; Joint Dislocation; Metal Related Pathology

  MAUDE report 16016555 ↗
• InjurySep 8, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2018 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. A REVISION SURGERY WAS PERFORMED TO ADDRESSED THIS ISSUE ON (B)(6) 2018 AND ALL IMPLANTS WERE EXCHANGED. 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 15385246 ↗
• InjuryJun 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LOOSENING OF IMPLANT. THIS ADVERSE EVENT WILL BE TREATED WITH A REVISION SURGERY IN THE NEXT 14 DAYS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 14627628 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A CONVERSION OF PARTIAL KNEE ARTHROPLASTY TO A TOTAL KNEE ARTHROPLASTY WAS PERFORMED DUE TO PAIN AND LOOSENING OF JOINT PROSTHESIS.

  Patient problems: Injury; Pain

  MAUDE report 8349327 ↗
• InjuryFeb 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS COMPLAINING OF PERSISTENT PAIN AND SWELLING, LONGER THAN USUAL. HE TOOK AN X-RAYS ON (B)(6) 2019 SHOWING A SUSPICIOUS FRACTURE. HE DENIED ANY FALL INJURY. CLINICALLY, THERE WAS PERSISTENT EFFUSION. KNEE ASPIRATION YIELDED 30ML STRAW COLOURED JOINT FLUID WAS SENT FOR CULTURE. SMEAR WAS NEGATIVE. URGENT CT CONFIRMED A MEDIAL TIBIAL PLATEAU FRACTURE. A REVISION WAS PERFORMED ON JANUARY 24TH, DUE TO THE TIBIAL BASEPLATE WAS BROKE, AND THE FEMORAL COMPONENT AND INSERT WERE ALSO REMOVED.

  Patient problems: Pain

  MAUDE report 8334117 ↗

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