JOURNEY 74022126Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00885556170465), received between Jul 26, 2017 and Apr 29, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED PERIPROSTHETIC INFECTION CONFIRMED EVEN WITH NEGATIVE CULTURES. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2026. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 25027614 ↗
• InjuryMay 30, 2025Loosening 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 ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING OF THE FEMUR AND THE TIBIA COMPONENTS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JRNY II BCS FEMORAL OXIN LT SZ 6, GNS II RESURF PAT 35MM, JOURNEY TIBIA BASE NP LT SZ 5 AND JRNY II BCS CNSTRD ART ISRT 5-6 LT 9M WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 22115214 ↗
• InjuryApr 24, 2025Adverse 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) 2015, THE PATIENT EXPERIENCED PATELLO-FEMORAL PAIN AND LATERALIZATION OF PATELLA ON (B)(6) 2021. A FOLLOW UP WAS MADE ON (B)(6) 2025 WHERE AND ASSESSMENT FOR PATELLO-FEMORAL SYMPTOMS WAS MADE AND A REPLACEMENT WAS PLANNED FOR AN UNKNOWN DATE.

  Patient problems: Pain

  MAUDE report 21900994 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY ON (B)(6) 2022, DUE TO ARTHRITIS OF LEFT KNEE AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, THE PATIENT FELL AND REPORTED PAIN, SFIFFNESS, SWELLING, AND ACUTE NEW SPONTANEOUS HEMARTHROSIS IN THE LEFT KNEE, AND POSSIBLE SMALL PARTIAL QUAD TENDON TEAR WAS DIAGNOSED ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT SUFFERED FROM CONTINUED HEMARTHROSIS THAT HAS RECURRED AFTER KNEE ASPIRATION 2 WEEKS AGO. 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: Hemarthrosis; Loss of Range of Motion; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 21547652 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2021, DUE TO ARTHRITIS AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED A PERIPROSTHETIC JOINT INFECTION (CULTURE SHOWED STAPH EPIDERMIDIS). THIS EVENT WAS TREATED WITH DEBRIDEMENT, ANTIBIOTICS, IRRIGATION, AND RETENTION OF THE PROSTHESIS (DAIR) ON (B)(6) 2021. 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: Bacterial Infection

  MAUDE report 21541066 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2021, DUE TO ARTHRITIS AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED AN INCISION LINE ERYTHEMATOUS WITH DRAINAGE FROM 2MM OPENING IN MIDDLE OF SUTURE LINE ON (B)(6) 2021. LATER, TESTS CONFIRMED A PERIPROSTHETIC JOINT INFECTION (CULTURE GROWING E. FAECALIS). THIS EVENT WAS TREATED WITH DEBRIDEMENT, ANTIBIOTICS, IRRIGATION, AND RETENTION OF THE PROSTHESIS (DAIR). 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: Bacterial Infection; Erythema

  MAUDE report 21540643 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2020, DUE TO UNSPECIFIED REASONS AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED PAIN ON (B)(6) 2020 AFTER TKA, WITH VARUS SHIFT IN LIMB ALIGNMENT AND A MEDIAL PLATEAU STRESS FRACTURE, MINIMALLY DISPLACED. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. 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: Arthralgia; Deformity/ Disfigurement; Periprosthetic fracture

  MAUDE report 21539825 ↗
• InjuryFeb 4, 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) 2021, THE PATIENT PRESENTED KNEE PAIN. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO EXPLANT THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM DEVICE, THE JOURNEY TIBIA BASE NP LT SZ 5 DEVICE, THE JRNY II BCS FEMORAL OXIN LT SZ 6 AND THE GII OVAL RESURFACING PAT 35MM DEVICE. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

  Patient problems: Arthralgia; Pain

  MAUDE report 16301715 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE IMPLANTATION OF A JOURNEY II LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2020, PATIENT HAS BEEN PRESENTED A CHRONIC PAIN. PATIENT DEVELOPED AN ACUTE DVT ON LEFT GASTROCNEMIUS VEIN. THE PATIENT UNDERWENT A KNEE ASPIRATION ON (B)(6) 2021 WHERE LOOSENING OR INFECTION WAS RULED OUT. A CT WITHOUT CONTRAST WAS PERFORMED ON (B)(6) 2021 WHERE A SMALL JOINT EFFUSION WAS EVIDENCED. THE PATIENT STATED THAT THIS ADVERSE EVENT HAS NOT BEEN TREATED YET.

  Patient problems: Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 13081619 ↗
• InjuryDec 29, 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 PRESENTED AN UNSPECIFIED EVENT. A SYNOVECTOMY OF RIGHT KNEE WAS PERFORMED TO ADDRESS IT. THE EVENT IS STILL ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 11086921 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JOURNEY II BCS EUROPE CLINICAL STUDY: IT WAS REPORTED THAT A PATIENT SUFFER FROM ANTERIOR KNEE PAIN. THE OUTCOME IS NOT RESOLVED. 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 10312833 ↗
• InjuryJul 3, 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 THE LOOSENING OF FEMORAL COMPONENT AND PAIN. PRIMARY OPERATION WAS PERFORMED ON (B)(6) 2019. THERE WAS NO PROBLEM AT THAT TIME, AND THERE WAS NO FINDINGS OF INFLAMMATION LIKE ARTHROFIBROSIS, NOR INFECTION. ON (B)(6) 2020 REVISION SURGERY WAS PERFORMED AND FEMORAL COMPONENT, TIBIAL COMPONENT, INSERT AND PATELLA WERE REMOVED. THE FEMORAL COMPONENT WAS EASY TO REMOVE, BUT THE OTHER COMPONENTS WERE FIXED WELL. THERE WAS A LITTLE RESIDUE OF CEMENT ONTO NON-ARTICULAR SURFACE OF FEMORAL COMPONENT. PATIENT OUTCOME IS GOOD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10230726 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO AN ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 9711194 ↗
• InjuryJul 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD EFFUSIONS A YEAR AFTER PRIMARY TKA AND A UNSPECIFIED SURGERY WAS PERFORMED AS TREATMENT.

  Patient problems: Injury

  MAUDE report 8766053 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT LEFT KNEE ARTHROFIBROSIS. TREATMENT: ASPIRATION AND CLOSED MANIPULATION.

  Patient problems: Fibrosis

  MAUDE report 8493661 ↗
• InjuryFeb 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ELEVATED WHITE CELL COUNT IN LEFT JOINT FLUID POST-OP ¿ POSSIBLE INFECTED JOINT REPLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 8365009 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER TKA PATIENT HAS ONGOING PAIN AND SWELLING AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8305488 ↗
• InjurySep 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT TKA ANKYLOSIS AND EVENT WAS RESOLVED IN CLOSED MANIPULATION UNDER ANESTHESIA FOR WHICH SUBJECT WAS HOSPITALIZED.

  Patient problems: Injury

  MAUDE report 7915139 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TWO STEP REVISION SURGERY WAS PERFORMED DUE TO A PERI-PROSTHETIC JOINT INFECTION IN LEFT KNEE. IN FIRST STEP OF THE REVISION SURGERY, ON (B)(6) 2017, PATELLAR COMPONENT AND ARTICULAR INSERT WERE EXPLANTED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. AND ON (B)(6) 2017 THE TOTAL KNEE WAS REVISED TO PERFORM A REIMPLANTATION OF DEVICES.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7887744 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHROSCOPY AND LATERAL SCAR REMOVAL WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7338480 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS NEEDED TO PERFORM A JOINT EFFUSION OF THE LEFT KNEE.

  Patient problems: No Information

  MAUDE report 7313059 ↗
• InjuryOct 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6990846 ↗
• InjuryOct 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TREATED WITH REMEDIAL THERAPY (COUMADIN 7.5MG PO 1X1X4; LOVENOX 150MG SC 2X1X6) DUE TO DEEP VENOUS THROMBOSIS , INCLUDING EDEMA. THE EVENT WAS MARKED AS RESOLVED AND MILD.

  Patient problems: Thrombosis

  MAUDE report 6957317 ↗
• InjuryOct 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED AND HAD MEDICAL TREATMENT DUE TO LEFT KNEE PAIN.

  Patient problems: Injury; Pain

  MAUDE report 6928157 ↗
• InjurySep 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A JOINT ASPIRATION ON LEFT KNEE WAS PERFORMED DUE TO SWELLING.

  Patient problems: Joint Swelling

  MAUDE report 6863524 ↗

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-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• 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-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