JOURNEY 74024924Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556611425), received between Jun 17, 2021 and Sep 29, 2022 — classified as 2 injuries.

4 other recalls cover devices cleared under the same FDA submission (K111711, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA, THE IMPACTOR WAS INADVERTENTLY PLACED UPSIDE DOWN ON THE JRNY II BCS FEMORAL COCR LT SZ 4. THE PROBLEM WAS NOTICED ONCE THE IMPLANT WAS PLACED ON THE FEMUR WITH CEMENT, AND THE IMPACTOR DID NOT DISLODGE. SURGEON ATTEMPTED TO DISLODGE IT WITH A MALLET, WHICH THEN CAUSED A FRACTURE OF THE LATERAL CONDYLE. THE FRACTURE WAS REPAIRED WITH THREE (3) SCREWS AND REMAINDER OF PROCEDURE COMPLETED. THE SAME IMPACTOR WAS USED AND SURGERY WAS PROLONGED FOR 15-20 MIN. FRACTURE CAUSED PATIENT PROLONGED RECOVERY WITH ONLY PARTIAL WEIGHT BEARING, INCLUDING UNEXPECTED REHAB HOSPITAL CARE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15505394 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. THE REPORTED DEVICES WERE A JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3-4 LT 9MM, A JOURNEY TIBIA BASE NP LT SIZE 3 , A GENESIS II 7.5MM RESUR PATELLA 29MM AND A JRNY II BCS FEM COCR LT SZ 4. THE SURGEON STATED THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Unspecified Infection

  MAUDE report 12017384 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5