JOURNEY 74026168Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556677131), received between Jan 8, 2024 and Sep 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, AFTER A UKA SURGERY, HAD BEEN PERFORMED ON (B)(6) 2024, THE POLY INSERT PRESENTED AN ABNORMAL WEAR. THE PATIENT FELT PAIN IN HER KNEE OVER A LONG PERIOD OF TIME. THERE WAS NOT ONE EVENT THAT CAUSED IT. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JOURNEY II UK TIB INSRT MED SZ 5-6 8MM WAS EXCHANGED. THE PATIENT IS STILL IN THE RECOVERY PHASE OF THE CONVERSION SURGERY, HOWEVER, HAS BEEN RELIEVED OF MUCH OF THE PAIN THEY WERE EXPERIENCING FOLLOWING THE ORIGINAL PARTIAL KNEE REPLACEMENT.

  Patient problems: Pain

  MAUDE report 23151742 ↗
• InjuryApr 11, 2025Dent in Material; Dent in Material

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2023, A REVISION SURGERY TOOK PLACE ON (B)(6) 2025 DUE TO PAIN. AN UNKN JOURNEY II UNI KNEE IMPL AND IT WAS NOTICED THAT IT HAD A BIG DIVOT WHEN RETRIEVED. LATERAL COMPARTMENT WEAR WAS PROVIDED AS A POSSIBLE CAUSE. CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21827625 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE LITERATURE REVIEW "EARLY PERFORMANCE AND EFFICACY OF AN UPDATED UNICONDYLAR KNEE ARTHROPLASTY DESIGN: A REVIEW OF 73 CASES", IT WAS REPORTED THAT, AFTER UNDERGOING PRIMARY LEFT UKA ON (B)(6) 2019 DUE TO MEDIAL COMPARTMENT OSTEOARTHRITIS, ONE (1) PATIENT EXPERIENCED AN UNSPECIFIED COMPLICATION THAT WAS TREATED WITH A POLY EXCHANGE, ALONG WITH IRRIGATION AND DEBRIDEMENT, ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 18463558 ↗

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