JOURNEY 74027231Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00885556179017), received between Mar 27, 2017 and Mar 11, 2025 — classified as 51 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA REVISION SURGERY PERFORMED ON (B)(6) 2025, THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2025 DUE TO INFECTION, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21572739 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH DAIR WAS PERFORMED AND THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21532689 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED THE KNEE LOOSE IN EXTENSION, THIS WAS DETERMINED BY THE SURGEON. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXPLANTED AND A J2 BCS 3-4 13MM XLPE POLY WAS IMPLANTED TO CORRECT THE LOOSENESS ISSUE. CURRENT HEALTH STATUS IS UNKNOWN, HOWEVER, THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 20758452 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) -2024, IN WHICH IRRIGATION AND DEBRIDEMENT WAS PERFORMED. ALSO, ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20257301 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A SUSPECTED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY PERFORMED ON (B)(6) 2024 IN WHICH ONLY THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXPLANTED. THE FEMORAL COMPONENT, TIBIAL BASEPLATE AND PATELLA COMPONENT WERE REMAINED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19085108 ↗
• InjuryMar 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, A LEFT SIDED JOURNEY BCS TKA HAD BEEN PERFORMED ON (B)(6) 2023, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS USED. THE OPERATION WENT WELL AND THE PATIENT WAS DISCHARGED. DURING A FOLLOW-UP IT WAS NOTICED THAT THE LABEL FOR THE INSERT USED WAS FOR A RIGHT SIDED INSERT. BASED ON AN INVESTIGATION, IT DOES APPEAR THAT A RIGHT BCS INSERT WAS IMPLANTED INTO A LEFT KNEE. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843164 ↗
• InjuryFeb 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2021, A REVISION SURGERY HAD TO BE CARRIED OUT ON (B)(6) 2024, SINCE THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM DISLOCATED, AND THE PATIENT EXPERIENCED PAIN. THE INSERT AND PATELLA WERE EXCHANGED FOR S+N IMPLANTS. PATENT'S CURRENT HEALTH STATUS IS UNKNOWN, FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 18693248 ↗
• InjuryDec 9, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A RIGHT TKA REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DUE TO PAIN AND WEAR OF THE INSERT. PRIMARY SURGERY WAS CARRIED OUT ON (B)(6) 2022. DURING THE REVISION ONLY THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXCHANGED TO A JOURNEY II BCS INSERT. NO OTHER COMPLICATIONS WERE REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18298352 ↗
• InjuryDec 5, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A BILATERAL TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, IN (B)(6) 2023 A DISLOCATION OCCURRED, THE PATIENT FELL WHILE STANDING UP. TWO WEEKS LATER A CLOSED REDUCTION WAS PERFORMED AND ANOTHER FALL AND DISLOCATION OCCURRED THE SAME NIGHT. ONE WEEK LATER ANOTHER CLOSED REDUCTION WAS PERFORMED. AT LAST, THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2023, IN WHICH IT WAS FOUND THAT THE POST OF THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS BROKEN OFF SO IT WAS EXCHANGED. THE SURGEON STATED THAT THE BREAKAGE OF THE INSERT WAS DUE TO SECOND FALL AND DISLOCATION. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall; Joint Dislocation

  MAUDE report 18268395 ↗
• InjuryNov 6, 2023Adverse 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) 2023, THE PATIENT EXPERIENCED INFECTION. A REVISION SURGERY AND DEBRIDEMENT WERE PERFORMED ON THE 10-OCT-2023 TO TREAT THIS ADVERSE EVENT IN WHICH A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS EXCHANGED WHILE A JRNY II BCS FEMORAL OXIN RT SZ 6, JOURNEY TIBIA BASE NP RT SZ 4 AND A GEN II 7.5MM RESUR PAT 29MM REMAINED. IN ADDITION, THE SURGEON DOES NOT BELIEVE THAT THE PRODUCT IS AT FAULT. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18074090 ↗
• MalfunctionSep 5, 2023Positioning Failure; Material Deformation; Scratched Material; Positioning Failure; Material Deformation; Scratched Material

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM COULD NOT BE SEATED ONTO THE BASEPLATE. IT WAS OBSERVER THAT THE IMPLANT WAS SCRATCHED AND DEFORMED. THE SURGEON CHECKED THAT THERE WERE NO BONE CEMENT AND SOFT TISSUE ON THE BASEPLATE. HOWEVER, THE PROBLEM DID NOT CHANGE AFTER SEVERAL ATTEMPTS. THE SURGEON FELT THE 9MM INSERT WAS A LITTLE BIG. THE PROCEDURE WAS COMPLETED AFTER A 40-MINUTE SURGICAL DELAY USING A 10MM INSERT AS ALTERNATIVE. THERE WAS NO ADDITIONAL/UNPLANNED BONE REMOVAL AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687721 ↗
• InjuryAug 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A FALL AND KNOCKED THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM DEVICE OUT OF THE TIBIAL TRAY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY TO SWAP THE POLY. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Insufficient Information

  MAUDE report 17541286 ↗
• InjuryJun 11, 2023Adverse 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 INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS REMOVED. PATIENT'S CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 17102353 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DISLOCATION. THE INSERT WAS EXCHANGED DURING THIS REVISION AND OTHER IMPLANTS WERE REMAINED. THE PRODUCT CANNOT BE RETURNED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17065873 ↗
• MalfunctionApr 30, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY IT WAS NOT POSSIBLE TO IMPLANT A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM. THE SURGEON USED A SECOND ONE OF THE SAME REFERENCE WHICH DID NOT CAUSE ANY PROBLEM. THE SURGEON HAD TO USE ADDITIONAL ANESTHESIA TO COMPLETE SURGERY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841522 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNKNOWN SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION, IT IS UNKNOWN WHAT TYPE OF INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. THE PHYSICIAN CONFIRMED THAT THE DEVICES WERE NOT DEFECTIVE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12795849 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ANTERIOR KNEE PAIN DUE TO MAL-TRACKING OF PATELLA. THERE WAS A LATERALIZATION AND LOW PATELLAR TILT SHOWED ON A 5 YEAR X-RAY. POLYETHYLENE INLAY EXCHANGE WAS PERFORMED DUE TO ROUTINE. NO FEMORAL OR TIBIAL COMPONENT WAS EXTRACTED.

  Patient problems: Pain

  MAUDE report 11612124 ↗
• InjuryNov 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. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. THE INSERT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 10896999 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, PATIENT DEVELOPED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10836922 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA, PATIENT DEVELOPED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10836902 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN AND INFECTION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE IMPLANTS, ALTHOUGH THE SURGEON STATED THAT IMPLANTS WERE NOT DEFECTIVE. IT IS UNKNOWN IF EVENT WAS RESOLVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10689477 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INSTABILITY THE PATIENT REQUIRED A REVISION SURGERY TO EXCHANGE THE INSERT. IT'S UNKNOWN THE STATUS OF THE PATIENT.

  Patient problems: Injury

  MAUDE report 10127387 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION WAS PERFORMED BECAUSE THE PATIENT JUMPED OFF A HORSE AND FELL ON THE FROZEN GROUND ON THE RIGHT KNEE WITH THE PROSTHESIS. DURING THE REVISION, THE TIBIAL BASEPLATE COMPONENT SHOWED EXCELLENT CEMENT ADHERENCE. THE TIBIAL BASEPLATE AND ARTICULAR INSERT WERE REVISED AS PLANNED.

  Patient problems: Injury

  MAUDE report 9587384 ↗
• InjuryJan 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT RIGHT KNEE. PATIENT WAS HEALTHY AND THE REASON FOR REVISION WAS THE PATIENT JUMPED OFF A HORSE AND FELL ON FROZEN GROUND ON HIS RIGHT KNEE. TIBIAL BASEPLATE AND ARTICULAR INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 9580215 ↗
• InjuryDec 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION. THE INSERT WAS REMOVED.

  Patient problems: Injury

  MAUDE report 9495372 ↗

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