JOURNEY II XR 74023850Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556613177), received between Jan 31, 2019 and Feb 8, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Defective Device” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 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 13480664 ↗
• InjuryFeb 2, 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 13430296 ↗
• InjurySep 25, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING SURGERY, THE 8 MM INSERT COULD NOT INSERTED WELL. A 9MM BACK-UP INSERT WAS UTILIZED TO COMPLETE THE SURGERY. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10589624 ↗
• 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 LAT 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 10502776 ↗
• InjurySep 7, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING TKA SURGERY, THE JRNY II XR INS XLPE LAT 5-6 RT 8MM COULD NOT BE LOCKED WELL. SO A BACK UP OF THE SAME SIZE WAS OPENED AND ATTEMPTED TO BE INSERTED. THE BACK UP COULD NOT LOCKED WELL TOO. FINALLY, THE SIZE OF INSERT WAS CHANGED TO 9MM AND THEN IT WAS LOCKED WELL. NO DELAY REPORTED. NO OTHER COMPLICATIONS WERE REPORTED 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 Known Impact Or Consequence To Patient

  MAUDE report 10500277 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED DEEP SCAR TISSUE ON RIGHT KNEE. ADVERSE EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 10063638 ↗
• 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 LATERAL 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 10043927 ↗
• 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 9900952 ↗
• 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 8897944 ↗
• 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 8292312 ↗

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