JOURNEY II XR 74022204Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556615348), received between Sep 5, 2018 and Mar 30, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SCAR TISSUE DEBRIDEMENT ON THE LEFT KNEE. THE EVENT WAS TREATED VIA ARTHROSCOPY AND WAS RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9901063 ↗
• InjuryJun 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CLOSED MANIPULATION UNDER ANESTHESIA HAS BEEN DONE DUE TO STIFFNESS IN THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8746838 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT INCISION AND DRAINAGE WERE PERFORMED TO THE PATIENT DUE TO WOUND DRAINAGE CAUSED BY AN ALLERGIC REACTION TO SUTURES.

  Patient problems: Injury

  MAUDE report 8712745 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE INFLAMMATION 3 YEARS AFTER THE SURGERY AND PATIENT WAS GIVEN PREDNISONE.

  Patient problems: Inflammation

  MAUDE report 8079671 ↗
• InjuryNov 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAS COMPLAINED OF PAIN IN THE KNEE SINCE THE INITIAL PROCEDURE. REVISION SURGERY WAS PERFORMED. NO DELAY, ADDITIONAL INJURIES OR BACK UP REPORTED.

  Patient problems: Injury; Pain

  MAUDE report 8030428 ↗
• InjurySep 5, 2018Mechanics Altered

  IT WAS REPORTED THAT A LEFT KNEE PRESENTED STIFFNESS; DECREASED ROM. EVENT WAS TREATED WITH SURGICAL PROCEDURE - MANIPULATION UNDER ANESTHESIA. AEMB DISAGREED WITH INVESTIGATOR'S CLASSIFICATION THAT THIS EVENT IS UNRELATED AND HAS CLASSIFIED THIS EVENT ON (B)(6) 2018 AS SERIOUS ADVERSE DEVICE EFFECT (SADE), UNABLE TO EXCLUDE RELATIONSHIP OF S&N DEVICE AS CAUSE OR CONTRIBUTOR TO THIS SERIOUS INJURY, WITH SPECIAL EMPHASIS GIVEN TO SURGICAL TECHNIQUE.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 7846321 ↗

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