JOURNEY 74027232Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00885556179062), received between Oct 25, 2017 and Jun 19, 2025 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A MEDICAL DEVICE SITE INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM WAS SWAP AND WASH OUT. A NEW 3/4 10 MM DEVICE WAS INSERTED . THE CURRENT HEALTH STATUS WAS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22290535 ↗
• MalfunctionDec 22, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE STERILE BOX OF A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM WAS NOTICED TO BE NOT FULLY SEALED. THEREFORE THE STERILITY OF THE IMPLANT WAS QUESTIONABLE, 75% OF THE PACKAGE WAS OPEN AND 25% OF THE PACKAGE WAS SEALED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383073 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED POSTERIOR TIBIAL DISLOCATION. A REVISION SURGERY WAS PERFORMED ON THE (B)(6)2023 TO TREAT THIS ADVERSE EVENT IN WHICH A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM WAS EXCHANGED TO A JOURNEY II CONSTRAINED INSERT 12MM WHILE A GEN II 7.5MM RESUR PAT 26MM, JOURNEY TIBIA BASE NP RT SZ 3 AND A JRNY II BCS FEMORAL OXIN RT SZ 3 REMAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17641669 ↗
• InjuryJan 28, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING TKA SURGERY, PATIENT HAD INSTABILITY ISSUES WITH A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM, SO THE PHYSICIAN CHANGED THE INSERT AND PUT UN A CONSTRAINED INSERT TO RESOLVE THE INSTABILITY. IT IS UNKNOWN IF THERE WAS ANY DELAY. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 13389330 ↗
• InjuryApr 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS LOOSE AND HYPEREXTENDED; THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO SWAP A JOURNEY II BCS XLPE ART INSERT SIZE 3-4-RT 10MM. A 15MM INSERT WAS USED TO RECTIFY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 11648445 ↗
• InjuryApr 12, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED A LEGION HK GD MOTION INSERT LOCK SCREW WAS NOT LOCKED INTO THE LEGION HK TIBIA BASE PLATE ANYMORE. IT IS BELIEVED THAT THE SCREW PROBABLY IS ONLY LOCKED IN THE INSERT. A REVISION SURGERY COULD BE PERFORMED WITH A NEW SCREW.

  Patient problems: Failure of Implant

  MAUDE report 11648443 ↗
• InjuryMar 14, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE JOURNEY II BCS XLPE ART ISRT SIZE 3-4-RT 10MM INSERT COULD NOT BE PLACED TO BASEPLATE. THE PROCEDURE WAS COMPLETED WITH A 9MM INSERT WITHOUT FURTHER COMPLICATIONS OR DELAY. INSTRUMENTS INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478930 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT STARTED EXPERIENCING PAIN, WHICH WAS CAUSED BY SYNOVITIS. A REVISION SURGERY WAS PERFORMED TO TREAT THE EVENT. ALTHOUGH THE PHYSICIAN CLAIMS THAT THE DEVICES WERE NOT DEFECTIVE, THE JOURNEY II BCS XLPE INSERT WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Inflammation

  MAUDE report 10036655 ↗
• InjuryApr 27, 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. THIS ISSUE WAS CAUSED BY SYNOVITIS. THE INSERT WAS REMOVED. SURGEON REPORTED THAT THE DEVICE WAS NOT DEFECTIVE.

  Patient problems: Injury

  MAUDE report 10003043 ↗
• InjuryMar 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9857742 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RIGHT TOTAL KNEE ANKYLOSIS AND EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8834604 ↗
• InjuryJun 16, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND MID FLEXION INSTABILITY.

  Patient problems: Pain

  MAUDE report 8702657 ↗
• 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 8702653 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT ID: (B)(4). IT WAS REPORTED THAT THE PATIENT HAS A RIGHT KNEE BURSITIS. THE CAUSE OF THE BURSA INFLAMMATION IS UNKNOWN. ALSO IS UNKNOWN IF ANY IMPLANT HAS BEEN EXPLANTED TO THE PATIENT OR TREATMENT FOR THE BURSA INFLAMMATION.

  Patient problems: Injury; Joint Swelling

  MAUDE report 8217671 ↗
• InjuryOct 9, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO KNEE ARTHROFIBROSIS AND STIFFNESS WITH CORTISONE INJECTION INTO THE RIGHT KNEE.

  Patient problems: Fibrosis; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 7949476 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO KNEE ARTHROFIBROSIS AND STIFFNESS WITH CORTISONE INJECTION INTO THE RIGHT KNEE.

  Patient problems: Fibrosis; No Code Available

  MAUDE report 7949440 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE. THE PRODUCTS WAS DISPOSED AFTER THE SURGERY SO IT CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7611885 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DRAINAGE OF THE KNEE WAS DONE AND A LINER EXCHANGE WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7205735 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED REVISION SURGERY DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7070746 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION INDICATES THE PATIENT WAS READMITTED (B)(6) 2015 DUE TO MANIPULATION UNDER ANESTHESIA. THE PATIENT ALSO PRESENTED WITH SWELLING OF THE RIGHT KNEE ON (B)(6) 2016 HOWEVER NO TREATMENT WAS PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069967 ↗
• InjuryNov 17, 2017Failure to Align; Failure to Align

  IT WAS REPORTED, A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION OF THE INSERT.

  Patient problems: Injury

  MAUDE report 7041556 ↗
• InjuryNov 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON THE RIGHT KNEE FOR PATELLAR COMPONENT AND POLY EXCHANGE DUE TO KNEE PAIN, LEG PAIN, ASSOCIATED SWELLING AND LOOSENING OF INTERNAL PROSTHESIS RIGHT KNEE.

  Patient problems: Joint Swelling

  MAUDE report 7035674 ↗
• InjuryOct 25, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6975931 ↗

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