JOURNEY 74027243Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556177716), received between Jan 10, 2018 and Jan 9, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT'S POST OPERATIVE RANGE OF MOTION WAS 0-110 DEGREES. THE SURGEON INDICATED THAT AFTER THIS THE PATIENT WAS NON-COMPLIANT WITH PHYSIO AND DEVELOPED A FIXED FLEXION DEFORMITY OF APPROXIMATELY 7-10 DEGREES. THE SURGEON PERFORMED SEVERAL MANIPULATIONS UNDER ANESTHESIA, AFTER WHICH IT WAS POSSIBLE TO STRAIGHTEN THE PATIENT'S LEG AND REGAIN A RANGE A OF MOTION OF 0-110 DEGREES. NEVERTHELESS, THE PATIENT WAS STILL NON-COMPLIANT AND DEVELOPED A FIXED FLEXION DEFORMITY AGAIN OF 7-10 DEGREES. THE SURGEON THEN DECIDED TO PERFORM A REVISION SURGERY ON (B)(6) 2023 TO SOLVE THIS ISSUE. THE TIBIAL 11MM INSERT WAS REMOVED AND DOWNSIZED TO A NEW 9MM INSERT. THE SURGEON NOTICED THAT THE PATIENT HAD SIGNIFICANT SCAR TISSUE, WHICH COULD HAVE CAUSED THE FIXED FLEXION DEFORMITY. THE SURGEON WAS ABLE TO ACHIEVE 0-110 DEGREES RANGE OF MOTION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 18479813 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. DETAILS ABOUT THE SURGERY ARE UNKNOWN BUT THE SURGEON REPORTED THAT THE DEVICES IMPLANTED WERE NOT DEFECTIVE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11977302 ↗
• InjuryJun 23, 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 FROM SIZE 11 TO SIZE 15. PRIMARY ON (B)(6) 2020, REVISION ON (B)(6) 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10187009 ↗
• InjuryJan 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION, SWELLING, AND FEVER. ONLY THE INSERT WAS EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9648326 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, THE INSERT WAS NOT FULLY LOCKED. SO A 12MM BACK-UP DEVICE WAS UTILIZED. IT CAUSED 15 MINUTES DELAY OF SURGERY. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9632614 ↗
• InjuryAug 22, 2019Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT JOURNEY II BCS INSERTS WERE CHANGED DUE TO INFECTION OF BOTH KNEES. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Injury; No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 8920254 ↗
• InjuryApr 15, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO POLY INSERT JUMPED BECAUSE SHE SITTING WITH HER LEGS CROSSED. POLY WAS FOUND SLIGHTLY BROKEN AND WORN.

  Patient problems: Injury

  MAUDE report 8512711 ↗
• InjuryDec 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ONLY INSERT WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 8192320 ↗
• InjuryDec 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. 11MM INSERT WAS REPLACED TO 15MM INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8159781 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WOULD BE REQUIRED TO CORRECT A PATELLOFEMORAL MALTRACKING.

  Patient problems: Pain

  MAUDE report 7178307 ↗

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