JOURNEY 74027254Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556179512), received between Aug 30, 2017 and Jun 10, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN (B)(6) 2017. THE PATIENT EXPERIENCED A BROKEN POST OF THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH A 5-6 13MM BCS CONSTRAINED WAS IMPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Failure of Implant

  MAUDE report 19499565 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED AND THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM WAS EXPLANTED. NO FURTHER DETAILS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17393330 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA, A PATIENT FELL AND RUPTURED ITS CLOSURE. THE INSERT JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM WAS REPLACED WITH TREATMENT OF ANTIBIOTICS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fall

  MAUDE report 15312956 ↗
• MalfunctionFeb 15, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING TKA SURGERY IT WAS NOTICED THAT THE PLASTIC CAPSULE OF THE JOURNEY II BCS XLPE ART ISRT WAS MELTED AND DEFORMED RESULTING ALSO IN UNSTERILE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326607 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A DECREASED ROM ON THE RIGHT KNEE. A REVISION SURGERY WITH S+N TIBIAL INSERT WAS PERFORMED TO RESOLVE THE ADVERSE EVENT.

  Patient problems: Injury

  MAUDE report 10720618 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A SEPSIS ON THE PATIENT. THE DOCTOR REMOVED ALL THE IMPLANTS, DID A WASHOUT AND INSERT A CEMENT SPACER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9255832 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2018 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7394433 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFILTRATION WITH DEPO-MEDROL WAS PERFORMED DUE TO HYDROPS.

  Patient problems: Injury; Joint Swelling; Pain

  MAUDE report 7060325 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO COMPLAINING ABOUT SYNOVITIS, PAIN, INFLAMMATION AND CONTRACTURE OF LOWER RIGHT LEG.

  Patient problems: Inflammation; Injury; Joint Disorder; Pain

  MAUDE report 6829614 ↗

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-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; 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