JOURNEY 74026158Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556677063), received between Sep 15, 2022 and Sep 9, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K190085, K230653, K242711); 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.

• MalfunctionSep 9, 2025Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JOURNEY II UK TIB INSRT MED SZ 3-4 8MM COULD NOT BE FULLY SEATED ON THE BASEPLATE. THE SURGEON TRIED TO INSERT IT AGAIN, BUT THE INSERT WAS RATTLING AND NOT SECURE FIRMLY IN PLACE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE (9MM INSERT). NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012240 ↗
• InjurySep 15, 2022Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A PARTIAL KNEE REPLACEMENT WITH A JOURNEY II SYSTEM HAD BEEN PERFORMED ON (B)(6) 2022, THE INSERT SHOWED EARLY WEAR AND WAS MOVING AS THE KNEE WAS BENT, CAUSING METAL ON METAL RUBBING. METAL PARTICLES WERE DISTRIBUTED THROUGHOUT THE LEG CAUSING TAINTED TISSUE AS WELL. THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO CONVERT TO THA AS CONSEQUENCE. CURRENT HEALTH STATUS IS NOT KNOWN.

  Patient problems: Arthralgia; Failure of Implant; Infiltration into Tissue; Joint Laxity; Loss of Range of Motion

  MAUDE report 15434179 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190085, K230653, K242711. 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
• Z-1393-2023 · Mar 27, 2023 · Open, Classified
  JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
• Z-2132-2020 · Jan 28, 2020 · Terminated
  JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti
• Z-2133-2020 · Jan 28, 2020 · Terminated
  JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti