JOURNEY 71422374Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010627544), received between Mar 11, 2026 and Mar 11, 2026 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K073175, K081351, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED INCREASED DISCOMFORT IN THE RIGHT KNEE JOINT AFTER A FALL AND AFTER IMPLANTATION OF ONE (1) JRNY UNI TIBIAL BASE RM/LL SZ 4, ONE (1) JUNI COCR FB FEM SZ 4 RM LL AND ONE (1) JOURNEY UNI TIBINRT S3-4RM/LL8MM. EVEN BEFORE THE EVENT, THE JOINT WAS NOT COMPLETELY SYMPTOM-FREE WITH SWELLING STATES. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) LGN REV TIBIA BASE SZ 6 RT, ONE (1) LGN RK/HK HEMI SZ 5-6 LL/RM 5MM, ONE (1) LGN PRESSFIT STEM 14MM X 120MM, ONE (1) LEGION PS NP FEM SZ 6 RT AND ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 9MM WERE IMPLANTED. INTRAOPERATIVELY SHOWED COMPLETE ANTERIOR CRUCIATE LIGAMENT RUPTURE. THE TOTAL KNEE HAS INCREASED LAXITY, WITHOUT THE ANTERIOR CRUCIATE LIGAMENT, THE FEMORAL CONDYLES ARE OFFSET MEDIALLY. THE POST-OPERATIVE IMAGE SHOWS THE CORRECT IMPLANT POSITION. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Damage to Ligament(s); Deformity/ Disfigurement; Discomfort; Fall; Inadequate Osseointegration; Joint Laxity; Subluxation; Swelling/ Edema

  MAUDE report 24568310 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073175, K081351, K230653. 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