JOURNEY II XR 74022295Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556615430), received between Jul 19, 2018 and Sep 8, 2020 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 BASEPLATE SZ 5 RT, 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 10502712 ↗
• 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 10063658 ↗
• 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 9900947 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY TO WALK, RIGHT KNEE ANKYLOSIS AND SYNOVITIS POST-OPERATIVE. THE EVENT WAS RESOLVED PERFORMING AN UNSPECIFIED SURGICAL PROCEDURE.

  Patient problems: Injury

  MAUDE report 8897966 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DUE TO RIGHT KNEE INFLAMMATION, THE PATIENT HAS BEEN GIVEN MEDICATIONS SUCH AS VICODIN AND PREDNISONE.

  Patient problems: Inflammation

  MAUDE report 7705272 ↗

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