JOURNEY II XR 74023750Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556613108), received between Jan 31, 2019 and Apr 12, 2023 — 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.

• InjuryApr 12, 2023Migration; Migration

  IT WAS REPORTED THAT DURING A CLINICAL STUDY, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED RIGHT KNEE SEVERE PAIN AND INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. THE EXPLANTED DEVICES WERE: JRNY II XR INS XLPE MED 5-6 RT 8MM, JRNY II CR FEM COCR NP RT SZ 5, JRNY II XR BASEPLATE SZ 5 RT AND GII OVAL RESURFACING PAT 32MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 16728295 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JRNY II XR INS XLPE MED 5-6 RT 8MM , IT IS UNKNOWN WHY WAS THIS DEVICES EXPLANTED AND THE STATUS OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED OR IS AVAILABLE AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10502741 ↗
• 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 CR MEDIAL INSERT 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 10043920 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LEFT KNEE STIFFNESS. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9900951 ↗
• 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 8897953 ↗
• 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 8292249 ↗

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