JOURNEY 74025612Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556422731), received between May 23, 2017 and Nov 5, 2024 — classified as 3 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K121443, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2024Degraded; Fracture; Naturally Worn; Degraded; Fracture; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO INSTABILITY AND JRNY II CR ISRT XLPE RT SZ 1-2 10MM WEAR. THE INSERT WAS EXCHANGED TO JOURNEY II INSERT XLPE DEEP DISHED 12MM. THE FEMORAL COMPONENT AND BASEPLATE WERE RETAINED. IN ADDITION, THE PATELLA WAS ALSO REPLACED WITH A PATELLA COMPONENT BECAUSE IT HAD NOT BEEN REPLACED IN THE PRIMARY SURGERY. THE SURGEON DOESN'T THINK OF PRODUCT FAILURE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20606332 ↗
• MalfunctionNov 17, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA ON THE PATIENT'S RIGHT KNEE ON AN UNSPECIFIED DATE, THE PATIENT HAS BEEN EXPERIENCING METALLOSIS CAUSED DUE TO SEVERE DAMAGE OF THE JRNY II CR ISRT XLPE RT SZ 1-2 10MM. IT IS UNKNOWN IF A REVISION SURGERY HAS BEEN ALREADY MEDICALLY INDICATED OR SCHEDULED TO TREAT THIS ADVERSE EVENT. FURTHER DETAILS ON THE ACTUAL HEALTH STATUS OF THE PATIENT ARE UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12828806 ↗
• InjuryMay 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PATIENT HAD THE MENTAL DISORDER. THE PATIENT FELL DOWN AND DISLOCATED THE INSERT. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE. THE PRODUCTS CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE. PATIENT FELL DOWN DUE TO RESTLESSNESS CAUSED BY DELIRIUM, AND THE PATIENT SUFFERED POSTERIOR CRUCIATE LIGAMENT INJURY AS A CONSEQUENCE AND THEN INSERT WAS DISLOCATED. NO MORE MEDICAL INFORMATION OR REPORT WAS NOT AVAILABLE BECAUSE THE DOCTOR DETERMINED THIS REVISION WAS NOT CAUSED BY THE DEVICE FAILURE.

  Patient problems: Joint Dislocation

  MAUDE report 7489254 ↗
• InjuryMay 23, 2017Unstable; Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED WITH EXCHANGE OF A TIBIAL INSERT TO A THICKER DISHED ONE AS THE PATIENT WAS UNSTABLE IN THE KNEE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6583814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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