JOURNEY 74022114Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00885556169865), received between Jun 13, 2017 and Feb 20, 2026 — classified as 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2026, X-RAY SHOWED FRACTURE OF THE FEMORAL CONDYLE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2026, IN WHICH A JRNY II BCS FEMORAL OXIN RT SZ 4 WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 24401293 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY ON (B)(6) 2022, DUE TO ARTHRITIS OF RIGHT KNEE AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, THE PATIENT SUFFERED ON (B)(6) 2022 FROM STIFFNESS AND REQUIRED A MUA. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21547565 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORI ASSISTED RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED STIFFNESS (LIMITED RANGE OF MOTION). THIS ADVERSE EVENT WAS TREATED BY KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IS RECOVERED.

  Patient problems: Loss of Range of Motion

  MAUDE report 18694342 ↗
• InjuryDec 2, 2022Adverse 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. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JRNY II BCS FEMORAL OXIN RT SZ 4 AND A JOURNEY TIBIA BASE NP RT SZ 4 WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15901921 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SUFFER FROM A LATERALIZATION OF PATELLA ON X-RAY 5 YEAR. ANTERIOR KNEE PAIN IN STAIRS. THE PATIENT IS NOT RECOVERED, CLINICAL ISSUE IS NOT RESOLVED AT THIS TIME. 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 10292141 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY PATIENT HAD RIGHT KNEE TOTAL ANKYLOSIS AND WAS RESOLVED THROUGH HOSPITALIZATION AND A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8834586 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO RIGHT TOTAL KNEE ANKYLOSIS.

  Patient problems: Injury

  MAUDE report 8830497 ↗
• InjuryJun 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A NON-DISPLACED TIBIAL PLATEAU LONGITUDINAL FRACTURE ALONG TIBIAL BASEPLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8725693 ↗
• InjuryJun 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT PRESENTING ARTHROFIBROSIS SINCE MAY 3RD AND A WORSENING ANKYLOSIS.

  Patient problems: Fibrosis; Injury

  MAUDE report 8725679 ↗
• InjuryJun 16, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND MID FLEXION INSTABILITY. NO FURTHER DETAILS AVAILABLE.

  Patient problems: Pain

  MAUDE report 8702656 ↗
• InjuryMay 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT: CELLULITIS. EVENT WAS TREATED WITH MEDICATION AND IT RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 8589150 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT: CELLULITIS. EVENT WAS TREATED WITH MEDICATION AND IT RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 8561024 ↗
• InjuryApr 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT STUDY NO.: (B)(6) WAS REVISED DUE TO EXCESSIVE ADHESION AND LACK OF JOINT MOVEMENT;

  Patient problems: Injury

  MAUDE report 8560799 ↗
• InjuryApr 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  (B)(6) STUDY; SUBJECT: (B)(6). IT WAS REPORTED THAT PATIENT HAD PERSISTENT STIFFNESS IN RIGHT KNEE AFTER SURGERY. FOR THIS EVENT SUBJECT UNDERWENT MOBILISATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534366 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) STUDY; SUBJECT: (B)(6); ATRIAL FIBRILLATION. IT WAS REPORTED THAT PATIENT HAD ATRIAL FIBRILLATION WHICH WAS TREATED WITH MEDICATION AND HOSPITALISATION WAS PROLONGED.

  Patient problems: Injury

  MAUDE report 8534361 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO EXCESSIVE LACK OF MOTION, PAIN AND INFECTION. PATELLA WAS NOT REVISED. REPLACED WITH ZIMMER COMPONENTS. EXPLANTS DESTROYED.

  Patient problems: Unspecified Infection

  MAUDE report 8519383 ↗
• InjuryApr 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  POST-OPERATIVE LIMITED RANGE OF MOTION (70°) RIGHT KNEE AFTER TKA SURGERY. SUBJECT WAS HOSPITALISED. EVENT REPRESENTS A SERIOUS ADVERSE DEVICE EFFECT.

  Patient problems: Injury

  MAUDE report 8512691 ↗
• InjuryApr 8, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED EXCESSIVE ARTHROFIBROSIS OF RIGHT KNEE RESULTING IN SEVERE LIMITED RANGE OF MOTION AND DEVELOPMENT OF SCAR TISSUE RESULTING IN A CLOSED MANIPULATION.

  Patient problems: Injury

  MAUDE report 8491172 ↗
• MalfunctionMar 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED IN A STUDY THAT THE PATIENT HAD CELLULITIS AS A RESULT OF LYMPHANGITIS OVER THE ANTEROLATERAL ASPECT OF THE PROXIMAL TIBIA. THE KNEE WAS REPORTED AS WARM AND HYPERSENSITIVE; PATIENT ADMITTED TO HOSPITAL FOR IV ANTIBIOTIC REGIME TO TREAT. THE EVENT WAS ASSESSED BY THE REPORTER AS RELATED TO THE STUDY PROCEDURE AND THE POSSIBILITY OF THE DEVICE CAUSING OR CONTRIBUTING TO THE EVENT COULD NOT BE EXCLUDED.

  Patient problems: Unspecified Infection

  MAUDE report 8452367 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE ANKYLOSIS.

  Patient problems: Muscular Rigidity

  MAUDE report 8077424 ↗
• InjuryMay 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO WOUND BLEEDING.

  Patient problems: Injury

  MAUDE report 7521864 ↗
• InjuryMay 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FLUID ASPIRATION IN THE RIGHT KNEE WAS PERFORMED IN PATIENT.

  Patient problems: Aspiration/Inhalation

  MAUDE report 7521214 ↗
• InjuryMay 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO WOUND BLEEDING.

  Patient problems: Injury

  MAUDE report 7521213 ↗
• InjuryMay 4, 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 ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7487289 ↗
• InjuryFeb 9, 2018Incorrect Device Or Component Shipped; Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT A LEFT SIDE IMPLANT WAS IN A PACKAGE LABELED AS A RIGHT SIDE IMPLANT. THE INCORRECT IMPLANT WAS IMPLANTED BUT WAS NOTICED TO BE INCORRECT. THE LEFT COMPONENT WAS REMOVED AND A BACK-UP RIGHT COMPONENT WAS IMPLANTED. THE SURGERY WAS DELAYED BY MORE THAN TWO HOURS.

  Patient problems: Injury

  MAUDE report 7260080 ↗

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