JOURNEY II XR 74023811Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556615515), received between Apr 3, 2019 and Dec 17, 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.

• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A TKA REVISION SURGERY WAS PERFORMED AND THE SMITH & NEPHEW DEVICE JOURNEY II XR INSERT WAS RETRIEVED FROM THE PATIENT AND REPLACED WITH A COMPETITOR DEVICE DUE TO AN INFECTED RIGHT KNEE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11027734 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED A CASE OF INFECTION IN THE OPERATIVE SIDE. THE EVENT WAS RESOLVED VIA BOTH LINER EXCHANGE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10591609 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE, REVISION SURGERY WAS PERFORMED DUE TO THE PAIN AND LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL BASEPLATE. THE DOCTOR SAYS THE S+N DEVICES WERE NOT DEFECTIVE. BACKUP FROM SMITH & NEPHEW WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 10260770 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED AND HAD A REVISION FOR AN INFECTED RIGHT KNEE. LINERS WERE REVISED.

  Patient problems: Injury

  MAUDE report 9939066 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAIN. THE XR INSERTS WERE REPLACED.

  Patient problems: Pain

  MAUDE report 8480368 ↗

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