JOURNEY II XR 74023810Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556615508), received between Sep 21, 2021 and Jan 17, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED LATERAL DISLOCATION OF THE RIGHT KNEE JOINT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2021. PER THE COLLECTED EVIDENCE RELATED TO THE SUBJECT'S CLINICAL COURSE, SHE HAS RECOVERED FROM THIS PROCEDURE.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 16187841 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO METALLOSIS. ALSO THE PATIENT DEVELOPED SWELLING AND PAIN 10 MONTHS AFTER PRIMARY SURGERY. IN THE REVISION SURGERY DISSOCIATION OF THE JRNY II XR INS XLPE LAT 1-2 RT 8MM AND WEAR OF THE FEMORAL COMPONENT AND TIBIAL BASEPLATE WERE VERIFIED. THE EXPLANTED DEVICES WERE: JRNY II CR FEM OX NP RT SZ 2, JRNY II XR BASEPLATE SZ 2 RT, JRNY II XR INS XLPE MED 1-2 RT 8MM AND JRNY II XR INS XLPE LAT 1-2 RT 8MM. IN ADDITION, ACL WAS RUPTURED ON UNKNOWN DATE BEFORE REVISION SURGERY. PATIENT CURRENT HEALTH STATUS IS GOOD. ABRASION FOR BLACK DEPOSITS WAS USED TO TREAT THE METALLOSIS ON THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Damage to Ligament(s); Inflammation; Joint Dislocation; Metal Related Pathology

  MAUDE report 16184182 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED RIGHT KNEE INSTABILITY AND PATELLA SUBLUXATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION OF TIBIAL AND FEMORAL COMPONENTS ON (B)(6) 2019. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Subluxation

  MAUDE report 12511062 ↗

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