JOURNEY 74027212Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556178713), received between May 22, 2017 and Apr 2, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A LEFT PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, IT WAS FOUND THAT THE RIGHT INSERT WAS IMPLANTED INCORRECTLY. THE SURGEON DID NOT THINK IT WAS A PRODUCT FAILURE. THE INSERT DID NOT HAVE ANY ISSUE WITH THE PACKAGING OR LABELLING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 10MM WAS EXCHANGED TO A LEFT INSERT (JRNY II BCS XLPE ART ISRT SZ 1-2 LT 10MM). PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21752143 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON 2014, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 10MM. IT IS UNCLEAR WHY THE REVISION WAS CARRIED OUT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20873224 ↗
• InjurySep 22, 2024Adverse 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 ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN. TO ADDRESS THIS ADVERSE EVENT, THE PATIENT UNDERWENT REVISION SURGERY IN (B)(6) 2023. DESPITE THE REVISION, THE PATIENT IS STILL EXPERIENCING PAIN AND REQUIRES THE USE OF A LIMP TO WALK. THE PATIENT MENTIONED THAT THEY WERE COMPLIANT WITH THEIR PHYSICAL THERAPIST IN AN EFFORT TO RETURN TO THEIR PREVIOUS ACTIVITIES, INCLUDING BIKING, CARDIO, PILATES, AND YOGA; HOWEVER, THEY ARE NO LONGER ABLE TO PERFORM THESE ACTIVITIES. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 20275999 ↗
• InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND A FEELING OF UNWILLINGNESS.

  Patient problems: Pain

  MAUDE report 9419100 ↗
• InjuryNov 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED OF INFECTION. DEBRIDEMENT AND INSERT REPLACEMENT WERE PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8051520 ↗
• InjuryJun 22, 2018Adverse 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 INSERT DISASSOCIATION FROM BASEPLATE. THE SURGEON DOES NOT FAULT THE DEVICE.

  Patient problems: Injury

  MAUDE report 7631238 ↗
• MalfunctionNov 29, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE INSERT COULD NOT BE CONNECTED TO THE BASEPLATE. THE SURGEON TRIED TO INSERT SEVERAL TIME. IT SEEMS THAT THE LOCKING AREA DEFORMED. PLEASE PERFORM DIMENSIONAL INSPECTION. 40 MINUTES DELAY WAS REPORTED. THE SURGERY WAS COMPLETED WITH A BACKUP 11MM INSERT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Information

  MAUDE report 7066139 ↗
• InjuryMay 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON DOESN'T FAULT THE DEVICE BECAUSE THIS HAS HAPPENED 7 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 6581107 ↗

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