JOURNEY II XR 74022296Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556615447), received between Jan 31, 2019 and Feb 4, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2022Adverse 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 (B)(6) 2019 WITH A JOURNEY II XR SYSTEM, THE CLINICAL SUBJECT EXPERIENCED STIFFNESS IN THE KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXPLANT THE SYSTEM. THE CURRENT HEALTH STATUS OF THIS CLINICAL SUBJECT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 13456792 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A TKA SURGERY HAD BEEN PERFORMED IN WHICH A JOURNEY II TIBIAL BASEPLATE WAS IMPLANTED, THE CLINICAL SUBJECT PRESENTED STIFFNESS IN THE RIGHT KNEE. IT CANNOT BE EXCLUDED THAT THE ADVERSE EVENT IS LINKED TO THE SURGERY. THE EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 10043924 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY IN WHICH A JOURNEY II BASEPLATE COMPONENT WAS IMPLANTED, THE CLINICAL SUBJECT PRESENTED POST-OPERATIVE STIFFNESS AND PAIN. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT HAS RECOVERED.

  Patient problems: Arthralgia; Loss of Range of Motion

  MAUDE report 10021218 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE PATELLAR IMPINGEMENT AND CREPITUS. EVENT WAS TREATED WITH IRRIGATION AND DEBRIDEMENT

  Patient problems: Injury

  MAUDE report 10014585 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED THE FOLLOWING SYMPTOMS POST OPERATIVELY: RIGHT POPLITEAL TENDONITIS; RIGHT POSTEROLATERAL KNEE SOFT TISSUE IMPINGEMENT. IT WAS RESOLVED WITH UNSPECIFIED SURGICAL PROCEDURE.

  Patient problems: Injury

  MAUDE report 8897951 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT KNEE MANIPULATION WAS PERFORMED DUE TO THE PATIENT PRESENTED LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8292226 ↗

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