JOURNEY II XR 74023741Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556612842), received between May 10, 2019 and Sep 22, 2021 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A PATELLA INSTABILITY IN THE LEFT KNEE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2018. PATIENT OUTCOME AS BEEN RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 12511126 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS ADDRESSED BY PERFORMING A REVISION SURGERY: ALL COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10766984 ↗
• InjuryApr 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED STIFFNESS OF LEFT KNEE. EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9951762 ↗
• InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED FROM LEFT KNEE ARTHROFIBROSIS FOLLOWING A SURGERY. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9911095 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT LEG PAIN AND SWELLING. THE SUBJECT ALSO EXPERIENCED FLEXION CONTRACTURE DESPITE AGGRESSIVE EFFORTS AT PHYSICAL THERAPY. A REVISION WAS PERFORMED (B)(6) 2018 WITH A POLY EXCHANGE. UPON REMOVAL OF THE NODULE, THE KNEE COULD BE FULLY EXTENDED INDICATING THAT THE CAUSE OF THE PATIENT'S FLEXION CONTRACTURE WAS PRIMARILY ANTERIOR IMPINGEMENT IN THE INTERCONDYLAR NOTCH DUE TO FIBROUS NODULE FORMATION

  Patient problems: Pain

  MAUDE report 9901046 ↗
• InjuryJun 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MUA WAS PERFORMED DUE TO STIFFNESS IN LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8681394 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN IN THE LEFT KNEE, WHICH WAS TREATED CONSERVATIVELY.

  Patient problems: Pain

  MAUDE report 8598894 ↗

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