JOURNEY 74022128Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556170564), received between Jul 5, 2017 and Oct 29, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 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 PERFORMED ON (B)(6) 2015, A SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO ANTERIOR KNEE PAIN AND MALTRACKING OF PATELLA, WHICH STARTED ON (B)(6) 2021 DURING THIS SURGERY THE PATELLA WAS REPLACED AND NONE OF THE COMPONENTS WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 23414078 ↗
• 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 NAVIO ASSISTED SURGERY ON (B)(6) 2021, DUE TO PRIMARY OA LEFT KNEE AND IN WHICH JOURNEY II COMPONENT(S) WERE IMPLANTED, PATIENT SUFFERED ON (B)(6) 2022 FROM DECREASED RANGE OF MOTION, IN LEFT KNEE, CHILLS, CELLULITIS AND JOINT INFECTION. ON (B)(6) 2022, THE PATIENT UNDERWENT A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE TO TREAT THE JOINT INFECTION WITH MSSA: METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. 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 21547371 ↗
• 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 NAVIO ASSISTED SURGERY ON (B)(6) 2021, DUE TO PRIMARY OA LEFT KNEE, AND IN WHICH A JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUFFERED ON (B)(6) 2022 FROM AN UNSPECIFIED COMPLICATION THAT REQUIRED A MUA PROCEDURE. 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: Loss of Range of Motion

  MAUDE report 21547275 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT HAS EXPERIENCED ONGOING PAIN A SWELLING. THIS ADVERSE EVENT HAS BEEN TREATED BY MULTIPLE APPROACHES, INCLUDING A KNEE ASPIRATION AND STEROID INJECTION ON (B)(6) 2018. BONE SCANS CONFIRMED LARGE JOINT EFFUSION AND PATELLAR MALTRACKING, FOR WHICH, ON (B)(6) 2018, BILATERAL KNEE RELEASE WAS PERFORMED TO ADDRESS THIS KNEECAP POSITIONING PROBLEM. A SECOND KNEE ASPIRATION WAS PERFORMED ON (B)(6) 2019. PATIENT'S PAIN AND SWELLING IS STILL ONGOING.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19121489 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID.: (B)(6); SUBJECT ID: (B)(6); AE NO.: AE04 IT WAS REPORTED THAT AFTER A TKR SURGERY, PERFORMED ON (B)(6) 2012, WHERE THE FOLLOWING DEVICES WERE IMPLANTED: JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 , JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 7-8 LEFT 9MM , JOURNEY TIBIAL BASEPLATE NONPOROUS LEFT SIZE 8 AND GENESIS II RESURFACING PATELLA 38MM. ON (B)(6) 2012 THE PATIENT PRESENTED A LYMPHEDEMA ON THE LEFT LEG (WHERE THE DEVICES WERE IMPLANTED), ADVERSE EVENT WAS TREATED WITH PHYSICAL THERAPY BUT WAS NOT RESOLVED. PATIENT DIED OF MYELODYSPLASTIC SYNDROME ON (B)(6) 2018, THIS DEATH CAUSE IS NOT RELATED TO THE IMPLANTED DEVICES.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12295064 ↗
• 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 ON (B)(6) 2017, THE PATIENT EXPERIENCED LEFT KNEE PAIN. THIS ADVERSE EVENT RESULTED IN A REVISION SURGERY WHERE A JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 (CASE (B)(4)) AND A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 11MM (CASE (B)(4)) WERE EXPLANTED. THIS WAS TREATED ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 12076660 ↗
• InjuryMay 19, 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 PAIN AND SWELLING FROM INFECTION. A PREVIOUS WASHOUT AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2021. AFTER THIS PROCEDURE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE JRNY II BCS FEMORAL OXIN LT SZ 8 WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 11849037 ↗
• InjuryMar 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN ALONG WITH SNAPPING AND GRINDING OVER THE ANTEROLATERAL ASPECT OF THE KNEE.

  Patient problems: Pain

  MAUDE report 8420926 ↗
• InjuryFeb 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DR. PERFORMED A LEFT KNEE REPLACEMENT ON HIS PATIENT ON THE (B)(6)2018. SHE COMPLAINED OF PERSISTENT PAIN AND STIFFNESS AND DR. DIAGNOSED HER WITH SEVERE ARTHROFIBROSIS. HE TOOK HER BACK TO THEATRE ON (B)(6) 2019 AND REVISED THE FEMORAL COMPONENT TO ONE SIZE SMALLER AND EXCHANGED THE INSERT. NO MORE INFORMATION SHOWN.

  Patient problems: Pain

  MAUDE report 8327003 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT LOST RANGE OF MOTION DUE TO ARTHROFIBROSIS AFTER TKA AND UNDERGO MANIPULATION UNDER ANESTHESIA TO REGAIN ROM.

  Patient problems: Injury

  MAUDE report 7042440 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SEEN IN THE ER AND DIAGNOSED WITH LEFT LEG CELLULITIS. HE WAS AMBULATORY TREATED WITH ORAL ANTIBIOTICS (500MG CEPHALEXIN 5 DAYS 3X1 AND BACTRIM 800/16MG 5 DAYS 2X1) BUT WAS LATER ON DUE TO WORSENING OF SYMPTOMS ADMITTED FOR ONE NIGHT IN HOSPITAL ON (B)(6) 2017 WHERE HE WAS TREATED WITH IV ANTIBIOTIC (CLINDAMYCIN 300MG IV) AFTER WHICH WAS RELEASED FOR HOME WITH CLINDAMYCIN 300MG P.O. 3 DAYS 4X1. ON (B)(6) 2017 PATIENT WAS ONCE MORE HOSPITALISED, TREATED I.V. ANTIBIOTICS (UNSPECIFIED) TO WHICH THE CONDITION IMPROVED, UNTIL FINALLY BEEN RESOLVED ON 3RD DAY OF HOSPITALISATION WHEN PATIENT WAS RELEASED HOME WITH AUGMENTIN 875MG 7 DAYS 2X1 AND DOXYCYCLINE HYCLATE 100MG 7 DAYS 2X1.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 6847629 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS POST TKA PATIENT HAD SWELLING OF THE KNEE WHICH WAS TREATED WITH ASPIRATION AND DRAINAGE AND 10 DAY BACTRIM ANTIBIOTIC THERAPY.

  Patient problems: Impaired Healing

  MAUDE report 6837297 ↗
• InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SURGICAL PROCEDURE OCCURRED FOR MANIPULATION OF LEFT KNEE DUE TO STIFFENING.

  Patient problems: Loss of Range of Motion

  MAUDE report 6691479 ↗
• InjuryJul 5, 2017Insufficient Device Problem Information

  IT WAS REPORTED THROUGH RETROSPECTIVE CLINICAL TRIAL THAT PATIENT REQUIRED REMEDIAL THERAPY AND OTHER CONSERVATIVE APPROACH IN ORDER TO SOLVE LEFT KNEE STIFFNESS AND SWELLING. OUTCOME OF THIS EVENT HAS BEEN REPORTED AS RESOLVED WITH RESIDUAL EFFECTS ON (B)(6) 2014 AND SEVERITY WAS DEEMED AS MILD.

  Patient problems: Muscular Rigidity; Swelling

  MAUDE report 6686268 ↗

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