JOURNEY 74029266Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556176665), received between Dec 4, 2015 and Jan 7, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K140555, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST TKA REVISION SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED PAIN AND INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JRNY II BCS CNSTRD ART ISRT 5-6 LT 15M WAS EXCHANGED TO A 15MM BCS. UPON OPENING THE KNEE IT WAS NOTICED THAT THE RESURFACING PATELLA HAD AN INDENTATION MOST LIKELY TO BE RESULT OF CONTACT WITH THE POST OF THE CONSTRAINED POLY. IT WAS PERFORMED A COMPLETE SYNOVECTOMY, SOME ADDITIONAL HEREOTOPIC BONE WAS ALSO REMOVED. KNEE AND BASEPLATE WAS WELL FIXED. PATHOLOGY SHOWED NO ACTIVE INFECTION. THE INITIAL RANGE OF MOTION WAS VERY GOOD AND THERE WAS NO PATELLA/POST CONTACT AT MAX FLEXION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Extraskeletal ossification; Joint Impingement; Joint Laxity; Loss of Range of Motion; Pain; Scar Tissue; Synovitis

  MAUDE report 18461333 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2017 DOCTOR ELECTED TO ASPIRATE 10CC OF BLOOD-TINGED FLUID ON FROM PATIENT'S KNEE JOINT, 12 DAYS LATER DOCTOR INJECTED 20.5MCI OF TC 99M HDP DUE TO PAIN AND SWELLING.

  Patient problems: Pain; Swelling

  MAUDE report 7953786 ↗
• InjuryDec 4, 2015Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN CREATING THE INSTABILITY IN THE KNEE. THE ARTICULAR INSERT WAS EXCHANGED AND THE ARTHROPLASTY WAS REINFORCED WITH ALLOGRAFT.

  Patient problems: Bruise/Contusion; Pain; Swelling

  MAUDE report 5268833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555, 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