JOURNEY II XR 74023962Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556615980), received between May 28, 2020 and May 28, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryMay 28, 2020Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED RIGHT KNEE STIFFNESS POST RIGHT TOTAL KNEE ARTHROPLASTY. EVEN WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 10098972 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [STUDY: JOURNEY II XR; SUBJECT ID: (B)(6); AE#: 2] IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN WHICH A JOURNEY II XR SYSTEM WAS IMPLANTED, THE CLINICAL SUBJECT SUFFERED FROM A (B)(6) INFECTION. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE EVENT IS RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 10096950 ↗

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