JOURNEY 71422362Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010627452), received between May 31, 2021 and May 31, 2021 — 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.

• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2020 THE PATIENT HAD 11 DEGREES OF VARUS KNEE ALIGNMENT WHICH WAS CORRECTED TO NEUTRAL DURING UKR OF MEDIAL COMPARTMENT ON (B)(6) 2020. ON (B)(6) 2020, PATIENT PRESENTED PAIN IN THE LATERAL KNEE COMPARTMENT. THEREFORE, ON (B)(6) 2020 THE PATIENT HAD A UKA OF THE LATERAL COMPARTMENT. THE PRE-OPERATIVE AND 3 MONTHS POST-OPERATIVE RADIOGRAPHIC EVALUATION COULD POSSIBLY EXPLAIN THE OVERLOADING OF LATERAL COMPARTMENT AND SUBSEQUENT NEED FOR ADDITIONAL UKR ON THE LATERAL SIDE. ON (B)(6) 2021, THE PATIENT FOLLOWING IMPLANTATION OF AN ADDITIONAL UNI KNEE PROSTHESIS INTO THE SAME KNEE, EXPERIENCED LOOSENING OF THE INITIAL (MEDIAL) UNI KNEE TIBIAL COMPONENT. THEREFORE, ON (B)(6) 2021 THE PATIENT HAD ANOTHER REVISION SURGERY WHERE BOTH UNI KNEES WERE EXPLANTED AND A TKA WAS IMPLANTED. THE EXPLANTS ARE NOT AVAILABLE FOR ANALYSIS, NOR OPERATIVE REPORTS AND X-RAYS YET.

  Patient problems: Pain

  MAUDE report 11909295 ↗

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