JOURNEY 74027241Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556177617), received between Oct 25, 2017 and Feb 8, 2026 — classified as 33 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2026Fracture

  IT WAS REPORTED THAT, AFTER A LEFT KNEE PATELLA SURGERY, IT WAS DISCOVERED THAT THE PLUG OF ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS BROKEN. THE TWO FRAGMENTS WERE CLEARLY IDENTIFIED AND COMPLETELY REMOVED. THE FRACTURE WAS PRESENT PRIOR TO ANY USE OF THE IMPLANT OR INSTRUMENTS IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288427 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SOME REDNESS AND HER WOUND STARTED TO DRAIN. THIS ADVERSE EVENT WAS SOLVED/TREATED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE KNEE WAS WASHED OUT AND A NEW JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS PUT IN . THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Erythema

  MAUDE report 21055386 ↗
• InjuryDec 30, 2024Adverse 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 ON (B)(6) 2018 AND A PATELLAR IMPLANTATION PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO UNKNOWN REASONS. DURING THIS SURGERY THE INSERT JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM AND PATELLAR COMPONENT GNS II BICONVEX PAT 26MM WERE EXCHANGED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Damage to Ligament(s); Insufficient Information; Joint Laxity

  MAUDE report 21036110 ↗
• InjuryAug 8, 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, THE PATIENT EXPERIENCED UNKNOWN SYMPTOMS, OR CONDITION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19939695 ↗
• MalfunctionJun 17, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE STERILE PACKAGE OF ONE (1) JRNY II BCS XLPE ARTISRT SZ 3-4 LT 9MM WAS OPENED, AND IT WAS FOUND OUT THAT THE INTERNAL PACKAGING WAS ALREADY OPENED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554967 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY FOR LEFT KNEE WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS RESOLVED BY REVISION SURGERY ON (B)(6) 2024, DURING WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS EXCHANGED, AND A NEW JOURNEY II BCS INSERT WAS IMPLANTED. THE FEMORAL COMPONENT, TIBIAL BASEPLATE, AND PATELLA COMPONENT REMAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18941216 ↗
• InjuryFeb 16, 2024Adverse 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 ON (B)(6) 2022 PATIENT EXPERIENCED FEVER, FEELING OF WRONGNESS AND INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS EXCHANGED TO JOURNEY II BCS INSERT. THE JRNY II BCS FEMORAL OXIN LT SZ 6, JOURNEY TIBIA BASE NP LT SZ 4, AND GNS II BICONVEX PAT 26MM WERE NOT EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fever; Medical device site infection; Unspecified Infection

  MAUDE report 18720094 ↗
• InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND DISLOCATED THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE INSERT WAS THE SWAPPED. PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17597037 ↗
• InjuryMay 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, AFTER A TKA SURGERY IN WHICH A JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM HAD BEEN IMPLANTED, THE PATIENT, AT SOME POINT, STARTED EXPERIENCING A LOOSE KNEE. THIS WAS SOLVED VIA A REVISION SURGERY ON (B)(6) 2023, DURING WHICH THE JRNY II BCS XLPE ART ISRT WAS EXPLANTED AND REPLACED WITH A THICKER POLYMER INSERT, WHICH WAS A SMITH & NEPHEW DEVICE. PATIENT CURRENTLY HAS NO HEALTH ISSUES DUE TO THIS ISSUE.

  Patient problems: Joint Laxity

  MAUDE report 16947706 ↗
• InjuryMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A CLUNKING KNEE WHEN ARTICULATING FROM FLEXION TO EXTENSION. MANIPULATION UNDER ANESTHESIA WAS PERFORMED BUT DID NOT RESOLVE THE ISSUE. THE PROBLEM WAS SOLVED BY A REVISION SURGERY IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS FOUND TO BE COMPLETELY SNAPPED AWAY FROM THE MAIN BODY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 13656191 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO INFECTION AND SWELLING. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13205582 ↗
• InjuryDec 14, 2021Adverse 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 ON (B)(6) 2021, THE PATIENT EXPERIENCED INFECTION, SWELLING AND FEVER FROM PRIMARY SURGERY. THIS ADVERSE EVENT WAS SOLVED BY DOING A REVISION SURGERY TO EXTRACT JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM ((B)(4) JRNY II BCS FEMORAL OXIN LT SZ 3 ((B)(4)), JOURNEY TIBIA BASE NP LT SZ 3 ((B)(4)) AND GNS II BICONVEX PAT 23MM ((B)(4)) ON (B)(6) 2021 AND IMPLANT COMPETITOR IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 13002237 ↗
• InjuryOct 27, 2021Adverse 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) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO AN UNSPECIFIED INFECTION. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. NO PATIENT HARMED REPORTED OTHER THAN THE DESCRIBED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12708052 ↗
• InjurySep 29, 2021Adverse 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 ON (B)(6) 2021, THE PATIENT EXPERIENCED SWELLING, FEVER AND INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS EXPLANTED. PATIENTS CURRENT HEALTH STATUS IN UNKNOWN.

  Patient problems: Fever; Swelling/ Edema; Toxemia

  MAUDE report 12551078 ↗
• InjuryJun 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS NOTICED THAT A JRNY II BCS XLPE ART ISRT SZ 3-4 LEFT 9MM IMPLANT WAS MISTAKENLY IMPLANTED DURING A RIGHT TKA SURGERY ON (B)(6) 2021. A REVISION SURGERY WAS PERFORMED TWO HOURS LATER TO REPLACE THE INSERT AND CORRECT THIS NEVER EVENT. THIS WAS AN INTRA-OPERATIVE ERROR. THE ¿SIDE¿ OF THE TIBIAL INSERT IMPLANT WAS INCORRECTLY READ AND CHECKED IN THEATRE THROUGH CLINICAL ERROR. THE ISSUE IS NOT ATTRIBUTED TO PACKAGING OR LABELING PROBLEMS. OTHER THAN HAVING TO RECEIVE AN IMMEDIATE REVISION, THE PATIENT HAS SUFFERED NO FURTHER PROBLEMS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086557 ↗
• InjuryJun 28, 2021Adverse 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 ON (B)(6) 2021, THE PATIENT EXPERIENCED INFECTION AND SWELLING THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021. A JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM WAS EXPLANTED. THE PATIENT´S OUTCOME IS UNKNOWN.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 12075231 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. THE REPORTED DEVICES WERE A JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3-4 LT 9MM, A JOURNEY TIBIA BASE NP LT SIZE 3, A GENESIS II 7.5MM RESUR PATELLA 29MM AND A JRNY II BCS FEM COCR LT SZ 4. THE SURGEON STATED THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Unspecified Infection

  MAUDE report 12017082 ↗
• InjuryOct 9, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE DOCTOR ATTEMPTED TO LOCK THE JOURNEY II ARTICULAR INSERT SIZE 3-4 LEFT 9 MM ONTO THE PLATE TIBIAL BASE PLATE NONPOROUS LEFT SIZE 3, BUT COULD NOT LOCKED WELL. AN ALTERNATIVE INSERT WAS TRIED THE JOURNEY II ARTICULAR INSERT SIZE 3-4 LEFT 10 MM BUT NEITHER COULD LOCK WELL. FINALLY THE DOCTOR INSERT THE JOURNEY II ARTICULAR INSERT SIZE 3-4 LEFT 9 MM BY HITTING HIM WITH A HAMMER AND CONSIDERED THE INSERT WAS SETTLED ONTO THE BASE PLATE. THERE WAS A 40 MINUTE DELAY FOR THIS EVENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10656989 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 LT 9MM WAS PERFORMED DUE TO PATIENT EXPERIENCED PAIN AND INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10604290 ↗
• InjuryJul 7, 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, PAIN, FEVER AND EXPANSION. THE DOCTOR SAID THE DEVICES WHICH HAD IMPLANTED WERE NOT DEFECT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10240956 ↗
• 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 9857756 ↗
• InjuryJan 27, 2020Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. FEMORAL AND TIBIAL IMPLANTS WERE TESTED FOR LOOSENESS AND WERE FOUND TO BE WELL FIXED. POLY WAS EXCHANGE.

  Patient problems: Injury

  MAUDE report 9631632 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE REQUIRING SUBSEQUENT ARTHROSCOPY.

  Patient problems: Injury

  MAUDE report 9485325 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE REQUIRING SUBSEQUENT ARTHROSCOPY.

  Patient problems: Injury

  MAUDE report 9485282 ↗
• MalfunctionMay 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING SURGERY A LEFT GENESIS II TIBIAL BASEPLATE (71420166) WAS IMPLANTED DURING A JOURNEY II TKA PROCEDURE. A J2 INSERT (74027241) WAS IMPLANTED AND LOCKED IN APPROPRIATELY TO THE GEN II TIBIAL BASEPLATE. NO DELAY WAS REPORTED AND NO BACKUP WAS NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604529 ↗

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