JOURNEY II XR 74023822Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556615577), received between Apr 29, 2020 and Sep 21, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LEFT KNEE INSTABILITY AND PATELLA SUBLUXATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION OF THE TIBIAL COMPONENTS ON (B)(6) 2018. PATIENT OUTCOME IS RESOLVED.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 12511094 ↗
• InjuryAug 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THERE WAS A DISLOCATION. IT IS BELIEVED THAT THE BASEPLATE HAD BEEN SET WITH WRONG DEGREE. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE JOURNEY II XR INS XLPE LAT 1-2 LT 10MM INSERT WAS EXCHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 10399878 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PATELLAR IMPINGEMENT ON THE LEFT KNEE. THE EVENT WAS TREATED WITH AN ARTHROSCOPIC SYNOVECTOMY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10012454 ↗

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