JOURNEY 74027282Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556178362), received between Dec 13, 2017 and Sep 16, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2015, THE POST BROKE ON BCS POLY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23062662 ↗
• InjuryMay 26, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA, SURGEON COULD NOT GET A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM TO SEAT INTO TIBIA BASE, SO WAS OPENED ANOTHER IDENTICAL INSERT AND THIS ALSO COULD NOT BE SEATED INTO TIBIAL BASE, FINALLY WAS OPENED A CONSTRAINED INSERT OF SAME SIZE AND INSERT SEATED PERFECTLY. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887255 ↗
• MalfunctionMay 26, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA, SURGEON COULD NOT GET A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM TO SEAT INTO TIBIA BASE, SO WAS OPENED ANOTHER IDENTICAL INSERT AND THIS ALSO COULD NOT BE SEATED INTO TIBIAL BASE, FINALLY WAS OPENED A CONSTRAINED INSERT OF SAME SIZE AND INSERT SEATED PERFECTLY. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886922 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BILATERAL KNEES SURGERY A FEW WEEKS AGO. HE LOST HIS BALANCE, FELL AND OPENED UP HIS INCISION. HE WAS BROUGHT TO THE HOSPITAL AND THE POLY WAS REMOVED SO THE JOINT COULD BE WASHED OUT. A NEW POLY OF THE SAME SIZE WAS REINSERTED. IT IS UNKNOWN IF THERE WAS ANY DELAY DURING THIS PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10570050 ↗
• InjuryMay 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A MANIPULATION UNDER ANESTHESIA DUE TO THE KNEE IS BARELY AT 60° OF FLEXION AND THE PATIENT CERTAINLY LACKS THE LAST 15 OR SO DEGREES OF EXTENSION. INTENSIFYING PHYSIOTHERAPY AND REHABILITATION IS FAILING TO MAKE ANY SIGNIFICANT OR MEANINGFUL PROGRESS.

  Patient problems: Injury

  MAUDE report 8643567 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DISLOCATED THEIR JII KNEE. SURGEON FIXED BY USING SIZE 7/8 13MM CONSTRAINED LINER IN PLACE OF THE LINER ON COMPLAINT.

  Patient problems: Joint Dislocation

  MAUDE report 7435444 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED AFTER LEFT TKA DUE TO ARTHROSCOPIC EXCISION OF HYPERTROPHIC SCAR.

  Patient problems: Injury; No Code Available

  MAUDE report 7111816 ↗

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