JOURNEY 74027245Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556177815), received between Dec 29, 2017 and Nov 10, 2020 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS. A REVISION SURGERY WAS PERFORM TO TREAT SUCH EVENT. THE PHYSICIAN NOTICED THAT THE JOURNEY II BCS XLPE ART INSERT SIZE 3-4 LEFT 13MM WAS LOOSE, SO AN EXCHANGE WAS MADE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10817144 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN IN THE LEFT KNEE. THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 13MM WAS REMOVED AND REPLACED WITH A LARGER POLY (LEFT SZ 3-4 18MM). NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10681802 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED INFECTION. THE INSERT WAS CHANGED TO ANOTHER FROM THE SAME SIZE 13 (74027245, 18EM11285). PRIMARY ON (B)(6) 2020, REVISION ON (B)(6) 2020. PROCEDURE: TKA. NO DELAY.

  Patient problems: Injury

  MAUDE report 10193731 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THIS WAS CAUSED BY SURGICAL WOUND OPENED DUE TO PATIENT'S ACTIVITY.

  Patient problems: Unspecified Infection

  MAUDE report 9875585 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD CELULLITIS IN LEFT LEG AND A SURGICAL PROCEDURE WAS REQUIRED TO RESOLVE IT.

  Patient problems: Cellulitis

  MAUDE report 8834594 ↗
• InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  JOURNEY II BCS RETRO STUDY; SUBJECT: (B)(6). IT WAS REPORTED THAT PATIENT HAD AN INFECTION TKA LEFT FOR WHICH A REVISION SURGERY WAS REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 8547230 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A DEBRIS-CONTAINING SYNOVITIS, LIKELY RELATED TO POLYMERIC WEAR OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8364628 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A TOTAL KNEE REPLACEMENT ON (B)(6) 2014. ON (B)(6) 2016 A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 8108059 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO LEFT KNEE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7882727 ↗
• InjuryDec 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY DUE TO INFECTION AND INFLAMMATORY REACTION TO THE POLYETHYLENE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 7154216 ↗

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