JOURNEY 74027222Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556177266), received between Mar 3, 2019 and Jan 8, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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.

• InjuryJan 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT HAD A FALLEN AND THE CENTRAL STUD HAD BROKEN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 1-2 LT 10MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Fall

  MAUDE report 18465019 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REVISE THE JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3 (CASE-(B)(4)), THE JOURNEY TIBIAL BASEPLATE NONPOROUS LT SZ 2 (CASE-(B)(4)), THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 1-2 LEFT (CASE-(B)(4)) 10MM AND THE GENESIS II OVAL RESURFACING PATELLAR 29MM (CASE-(B)(4)). THE REASON OF THE REVISION IS UNKNOWN, AS WELL AS THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12543629 ↗
• InjuryApr 23, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE JRNY II BCS XLPE ART ISRT SZ 1-2 LT 10MM WAS EXPLANTED; AFTER REMOVING IT, SCRATCHES/PITTING ON THE ARTICULAR SURFACE OF THE MEDIAL AND LATERAL SIDE OF THE IMPLANT WERE NOTICED. OSTEOLYSIS ON THE MEDIAL ANTERIOR PORTION OF THE TIBIA AND ON THE DISTAL MEDIAL AND LATERAL PORTION OF THE FEMUR BONE WAS ALSO NOTICED DURING THE SURGERY, BUT WAS NOT SEEN ON THE XRAY. THE SURGEON MADE A COMMENT ABOUT THE SURFACE OF THE TIBIAL INSERT AND WONDERED WHETHER THAT MAY HAVE BEEN CAUSED BY BONE CEMENT, HOWEVER THERE WERE NO BONE CEMENT PARTICLES PRESENT BY LOOKING AT THE SITE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11713255 ↗
• InjuryJul 29, 2020Adverse 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, THE PATIENT SUFFERED FROM INFECTION AND FEVER. THE ADVERSE EVENT WAS TREATED BY REVISING THE JRNY II BCS XLPE ARTICULAR INSERT SZ 1-2 LT 10MM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Bacterial Infection

  MAUDE report 10338622 ↗
• InjurySep 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9083268 ↗
• InjuryApr 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. INSERT WAS EXCHANGED. OTHER COMPONENTS WERE RETAINED. NO MORE INFORMATION REPORTED.

  Patient problems: Injury

  MAUDE report 8534332 ↗
• InjuryMar 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BILATERAL REVISION SURGERY WAS PERFORMED DUE TO INFECTION. INSERT WAS EXCHANGED. THIS IS LEFT SIDE REPORTING.

  Patient problems: Unspecified Infection

  MAUDE report 8384971 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5