JOURNEY 74027233Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556179116), received between Dec 12, 2017 and Sep 10, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Adverse 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) 2025, THE PATIENT FELL AND TORE HER QUAD TENDON. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM WAS EXCHANGED TO STABILIZE THE KNEE AFTER THE REPAIR QUAD TENDON TEAR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23020537 ↗
• InjuryApr 2, 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 SHOWED SIGNS OF INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A POLY SWAP WAS PERFORMED; ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM WAS REMOVED AND REPLACED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21752234 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2020, DUE TO ARTHRITIS AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021 FOR PATELLA RESURFACING AND POLY EXCHANGE. 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: Insufficient Information

  MAUDE report 21540062 ↗
• InjuryAug 15, 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 HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT STATED HER KNEE STARTED FEELING "LOOSE" ABOUT A MONTH AGO AND PRESENTED WITH HYPER-FLEXION PER THE SURGEON, ONCE EXAMINED. PATELLA WAS RESURFACED AT THE INDEX SURGERY. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY TO SWAP THE POLY ON (B)(6) 2023, WITH SIMILAR POLY INSERT ONLY 2MM THICKER TO HELP WITH STABILITY. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Joint Laxity

  MAUDE report 17553468 ↗
• InjuryAug 17, 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) 2017, THE PATIENT SUFFERED A SUPRACONDYLAR FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3-4 RIGHT 11MM TO INSERT A NAIL. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15242569 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A FEMUR FRACTURE CAUSED BY A FALL. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11 MM WAS EXCHANGED TO FIX THE FEMUR FRACTURE. NO OTHER IMPLANT WAS REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 15210900 ↗
• InjuryNov 22, 2021Adverse 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 AN UNKNOWN DATE, THE PATIENT PRESENTED WITH RIGHT MEDIAL LIGAMENT LAXITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12857275 ↗
• InjuryJun 18, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PROCEDURE, A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF BONE AND PAIN MADE BY THE PATIENT FALLING. THE REVISION SURGERY WAS NOT CAUSED BY SMITH & NEPHEW DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 10167324 ↗
• InjuryJun 8, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT DURING SURGERY, THE INSERT DID NOT SEAT ONTO THE BASEPLATE WELL. IT LOOKS THERE IS A 0.5MM GAP BETWEEN THE INSERT AND BASEPLATE. THE DOCTOR CONFIRMED THERE WAS NO THIRD BODY OR FOREIGN SUBSTANCE, BUT IT DID NOT WORK WELL. FINALLY, A BACKUP SIZE 10MM INSERT WAS UTILIZED. THIS EVENT CAUSED 30 MINUTES DELAY OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 10129989 ↗
• InjuryApr 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED 20 DAYS AFTER PRIMARY DUE TO INFECTION. THE JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 11MM WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9926243 ↗
• 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 9857688 ↗
• InjuryApr 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  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 8534369 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) STUDY; SUBJECT: (B)(6); AE#01: ATRIAL FIBRILLATION. IT WAS REPORTED THAT PATIENT HAD ATRIAL FIBRILLATION WHICH WAS TREATED WITH MEDICATION AND HOSPITALISATION WAS PROLONGED.

  Patient problems: Injury

  MAUDE report 8534365 ↗
• InjuryFeb 13, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  A REVISION SURGERY WAS PERFORMED DUE TO BASEPLATE HAD SUBSIDED AND BONE HAD FORMED AROUND IT. IT WAS REMOVED VIA FLEXIBLE OSTETOME AND PUNCH. FEMUR WAS REMOVED VIA GIGLI SAW AND FLEXIBLE OSTETOME. TIBIA, TEAMED TO 15 X 120, 4MM OFFSET USED, SIZE 3 BASEPLATE. ALL VIA STANDARD TECHNIQUE. TRIALLED. FEMUR, REAMED TO 15 X 160, SIZE 3. ALL VIA STANDARD TECHNIQUE. TRIALLED IMPLANTS WERE CEMENTED IN, 18MM CONSTRAINED TRIAL AND KNEE BALANCED AND THEN INSERTED. WOUND CLOSED.

  Patient problems: Injury

  MAUDE report 8334200 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A KNEE REPLACEMENT, A PATIENT HAD KNEE EFFUSION, TRICOMPARTMENTAL SYNOVITIS WITH HYPERTROPHIC SCAR AND LATERAL BONE SPUR, AND PLICA SYNDROM.

  Patient problems: Injury

  MAUDE report 7116641 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PES TENDONITIS AND ITB SYNDROME ALSO TREATED WITH STEROID INJECTION.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7110370 ↗

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