JOURNEY 74021164Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556422793), received between Nov 16, 2018 and Nov 11, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 25 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT AFTER A PRIMARY TKA SURGERY THAT WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED FEMORAL COMPONENT WEAR AND METALLOSIS. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2025. THE FEMORAL COMPONENT, INSERT AND TIBIAL BASEPLATE WERE EXCHANGED TO LEGION DEVICES. THE PATELLA COMPONENT WAS MAINTAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 23526330 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA WAS PERFORMED ON (B)(6) 2019 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED INSTABILITY DURING WALKING AND DAMAGE TO THE ACL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH THE IMPLANTS WERE EXCHANGED TO A JOURNEY II BCS SYSTEM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 19352121 ↗
• InjuryJul 10, 2023Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A TKA SURGERY ON (B)(6) 2020, THE PATIENT HAS EXPERIENCED FALLS. THE PATIENT APPEARED TO BE DOING WELL UNTIL A FEW MONTHS AGO. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO TREAT THIS ADVERSE EVENT, IN WHICH A JRNY II CR FEM OX NP LT SZ 4 WAS EXCHANGED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17295251 ↗
• InjuryMar 17, 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) 2019, THE PATIENT EXPERIENCED VEIN THROMBOSIS ON THE LEFT LOWER EXTREMITY. THIS ADVERSE EVENT WAS TREATED WITH MEDICATION & PHYSICAL THERAPY. PATIENT'S CURRENT HEALTH STATUS IS RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16569273 ↗
• InjuryJan 17, 2023Adverse 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) 2022, A REVISION SURGERY WAS REQUIRED ON (B)(6) 2022, IN WHICH THE PATIENT UNDERWENT AND INSERT EXCHANGE. THE INSERT WAS DOWNSIZED FROM A 10MM THICK TO 9MM THICK INSERT. THEN, ON (B)(6) 2022, THE PATIENT UNDERWENT AN ADDITIONAL REVISION DUE TO ARTHROFIBROSIS. DURING THIS PROCEDURE, ALL THE PROSTHESIS KNEE COMPONENTS WERE EXPLANTED. THE 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: Fibrosis

  MAUDE report 16190672 ↗
• InjuryDec 19, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED LUCENCY AND OSTEOLYSIS ANTERIOR TO THE LEFT KNEE. AT THE TIME, NO TREATMENT HAS BEEN PERFORMED, THUS THIS ADVERSE EVENT REMAINS UNRESOLVED. NO FURTHER INFORMATION IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 16008276 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY, THE PATIENT EXPERIENCE ACUTE PROXIMAL PERONEAL DEEP VEIN THROMBOSIS, THIS ADVERSE EVENT WAS RESOLVED BY MEDICATION. PATIENT WAS NOT HARMED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13545668 ↗
• InjuryMar 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE CLINICAL SUBJECT EXPERIENCED A LOOSE FEMORAL COMPONENT. TREATMENT HAS NOT BEEN PROVIDED FOR THIS DAMAGE/ DISABILITY, SO THE EVENT IS ONGOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11540461 ↗
• InjuryNov 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE JRNY II CR LOCK FEM IMPLANT IMPACTOR DID NOT RELEASE THE JRNY II CR FEM OX NP LT SZ 4 IMPLANT. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAY OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10859864 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORM DUE TO A FEELING WRONGNESS. S+N DEVICES WERE NOT DEFECTIVE. IT IS UNKNOWN HOW IS THE STATUS OF THE PATIENT.

  Patient problems: Injury

  MAUDE report 10513882 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED ARTHROFIBROSIS ON THE LEFT KNEE. ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 10063705 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PATELLAR IMPINGEMENT ON THE LEFT KNEE. THE EVENT WAS TREATED WITH AN ARTHROSCOPIC SYNOVECTOMY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10012498 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM LEFT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND IT'S CONSIDERED RESOLVED WITH RESIDUES.

  Patient problems: Injury

  MAUDE report 9901072 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS OF THE LEFT KNEE. THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 9253275 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO ARTHROFIBROSIS ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8867898 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8867686 ↗
• InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED A FALL. AN UNSPECIFIED SURGICAL PROCEDURE WAS PERFORMED DUE TO LEFT KNEE ARTHROFIBROSIS. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 8739739 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT INCISION AND DRAINAGE WERE PERFORMED TO THE PATIENT DUE TO WOUND DRAINAGE CAUSED BY AN ALLERGIC REACTION TO SUTURES.

  Patient problems: Injury

  MAUDE report 8712735 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH MEDICATION AND CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8704602 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED LEFT LOWER EXTREMITY NEURITIS. ADVERSE EVENT TREATED WITH MEDICATION. OUTCOME OF THE EVENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8704600 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8704598 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED LEFT LOWER EXTREMITY NEURITIS. ADVERSE EVENT TREATED WITH MEDICATION. OUTCOME OF THE EVENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8704595 ↗
• InjuryJun 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT SUBJECT DEVELOPED STIFFNESS DECIDED TO PROCEED WITH MUA WHICH RESOLVED THE EVENT.

  Patient problems: Injury

  MAUDE report 8681339 ↗
• InjuryJan 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LEFT KNEE ACL/BRIDGE LOOSENING. EVENT TREATED WITH CANNULATED SCREW FIXATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 8289523 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE INFLAMMATION 3 YEARS AFTER THE SURGERY AND PATIENT WAS GIVEN PREDNISONE.

  Patient problems: Inflammation

  MAUDE report 8079024 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, K230653. One submission often covers many models, so check the product and lot details in each record.

• 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