JOURNEY II XR 74023853Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556615720), received between Feb 5, 2019 and Feb 5, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K152726, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2019Break; Break

  IT WAS REPORTED THAT DURING OPERATION WHEN INSERTING XR INSERT (74023853/16FM13167), THE INSERT CANNOT BE INSERTED AND LOCKED ACCORDINGLY. FINALLY, THE LOCKING MECHANISM HAD BEEN BROKEN. SO THE BACK-UP DEVICE (74023854/16FM13168) WAS OPENED AND TRIED TO INSERT, BUT THE INSERT ALSO CANNOT BE INSERTED AND BROKE AGAIN. AFTER THAT, THE BACK-UP DEVICE (74023976/LOT UNKNOWN YET) WAS OPENED AND INSERTED, AND IT HAS BEEN FIT WELL AND COMPLETED THE SURGERY. THIS CAUSED 50 MINUTED DELAY OF THE SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307879 ↗
• MalfunctionFeb 5, 2019Break; Break

  IT WAS REPORTED THAT DURING OPERATION WHEN INSERTING XR INSERT, THE INSERT CANNOT BE INSERTED AND LOCKED ACCORDINGLY. FINALLY, THE LOCKING MECHANISM HAD BEEN BROKEN. SO THE BACK-UP DEVICE WAS OPENED AND TRIED TO INSERT, BUT THE INSERT ALSO CANNOT BE INSERTED AND BROKE AGAIN. AFTER THAT, THE BACK-UP DEVICE) WAS OPENED AND INSERTED, AND IT HAS BEEN FIT WELL AND COMPLETED THE SURGERY. THIS CAUSED 50 MINUTED DELAY OF THE SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305981 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152726, 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