JOURNEY 74021155Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556422847), received between Mar 8, 2018 and Jan 15, 2024 — classified as 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 16, 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.

• InjuryJan 15, 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 ON (B)(6) 2023, THE PATIENT EXPERIENCED BONE FRACTURE AND PAIN. THE INFERIOR POLE OF THE PATELLA FRACTURE AND PATELLAR TENDON RUPTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JRNY II CR FEM OX NP RT SZ 4, JOURNEY TIBIA BASE NP RT SZ 3 AND JRNY II CR ISRT XLPE RT SZ 3-4 11MM WERE EXCHANGED TO COMPETITOR PRODUCTS. IT IS POSSIBLE THAT THE BONE FRACTURE WAS DUE TO EXCESSIVE REHABILITATION OR THE INCREASE OF P-F PRESSURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Muscle/Tendon Damage; Pain

  MAUDE report 18511198 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14548178 ↗
• InjuryFeb 9, 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) 2020, THE CLINICAL SUBJECT SUFFERED FROM A FLEXION CONTRACTURE (ROM 90/0/0) (ONSET DATE: (B)(6) 2020). THIS ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA (MUA) ON (B)(6) 2020. PATIENT WAS RECOVERED ON (B)(6) 2021.

  Patient problems: Joint Contracture

  MAUDE report 11300068 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE LEFT LEG A DEEP VEIN THROMBOSIS WAS DEVELOPED BY THE PATIENT AFTER PROCEDURE. MEDICATION THERAPY WAS PERFORMED AS ACTION TAKEN AGAINST THE ADVERSE EVENT. THE PATIENT IS RECOVERING.

  Patient problems: Injury; Thrombosis

  MAUDE report 10601128 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO UNDERWENT TO A TKA, SUFFERED FROM RIGHT LOWER EXTREMITY CELLULITIS WHICH WAS TREATED AND RESOLVED WITH CEPHALEXIN MEDICATION. THIS EVENT IS BEING REPORTED BECAUSE THE AEMB BELIEVES THAT THE CONTRIBUTION OF SMITH+NEPHEW DEVICE TO THE SERIOUS INJURY EXPERIENCED BY A CLINICAL TRIAL SUBJECT CANNOT BE EXCLUDED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10591576 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CELLULITIS ON THE RIGHT KNEE AND LEG HAD PRESENTED. PATIENT DEVELOPED REDNESS AND SWELLING OF THE LEG. ADMITTED TO HOSPITAL FOR ANTIBIOTICS. EVENTUALLY RESOLVED WITHOUT LONG TERM PROBLEMS. HOME PHYSICAL THERAPY AND MEDICATION WERE PRESCRIBED FOR TREATMENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10339848 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE DEVICES MAY HAVE CONTRIBUTED TO CAUSE CEREBRAL VASCULAR ACCIDENT ON PATIENT. THE PATIENT NEEDED HOSPITALIZATION AND MEDICATION DUE TO THE REPORTED EVENT. PATIENT WAS GIVEN TPA, AND WAS TRANSFERRED TO PATIENT REHABILITATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Vascular System (Circulation), Impaired

  MAUDE report 10279906 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [STUDY: JOURNEY II XR; SUBJECT ID: (B)(6); AE#: 2] IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN WHICH A JOURNEY II XR SYSTEM WAS IMPLANTED, THE CLINICAL SUBJECT SUFFERED FROM A (B)(6) INFECTION. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE EVENT IS RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 10096953 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A PRIMARY TKA SURGERY HAD BEEN PERFORMED WITH A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED OCCASIONAL SWELLING AND PAIN. THE IMPLANTED TKR SYSTEM FAILED: IT IS BELIEVED THAT TIBIAL LOOSENING WAS IMPLICATED. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JOURNEY II CR FEMORAL COMPONENT. AN S&N LEGION SYSTEM WAS IMPLANTED INSTEAD. THE EVENT IS CONSIDERED AS RESOLVED.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 10027435 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT PRESENTED POSTOPERATIVE RIGHT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 10015770 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED STIFFNESS OF THE RIGHT KNEE FOLLOWING SURGERY. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA. THE OUTCOME OF THE EVENT IS CONSIDERED UNKNOWN.

  Patient problems: Injury

  MAUDE report 9983623 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS ON THE RIGHT KNEE JOINT. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9832139 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT WAS HOSPITALIZED DUE TO A FALL. THE PATIENT SUFFERED FROM WOUND DEHISCENCE DUE TO THE FALL AND SPENT 10 DAYS IN THE HOSPITAL.

  Patient problems: Injury

  MAUDE report 9832129 ↗
• InjuryJan 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN WITH RANGE OF MOTION

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 9581230 ↗
• InjuryAug 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN UNSPECIFIED POST OPERATIVE CONDITION. THE PROSTHESIS WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 8951741 ↗
• InjuryAug 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH ELIQUIS DUE TO LOWER EXTREMITY DEEP VEIN THROMBOSIS.

  Patient problems: Swelling

  MAUDE report 8886068 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PCL DEFICIENCIES. THE FEMUR WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 8821715 ↗
• InjuryJun 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED INTRA-OP MEDIAL TIBIAL PLATEAU FRACTURE WITH ORIF AND SUBSEQUENT HARDWARE REMOVAL DUE TO PERSISTENT PAIN. ADVERSE EVENT WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 8746862 ↗
• InjuryJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED PES ANSERINUS WHICH WAS TREATED USING REPEAT DEPO MEDROL STEROID INJECTIONS.

  Patient problems: Injury

  MAUDE report 8683715 ↗
• InjuryJun 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LIMITED RANGE OF MOTION DURING 6 WEEKS POST OP VISIT, AND IT PROCEEDED WITH MANIPULATION UNDER ANESTHESIA. POST OP VISIT AFTER MUA, THE PATIENT WAS GIVEN DYNASPLINT TO IMPROVE EXTENSION. 6 WEEKS POST MUA PATIENT'S RANGE OF MOTION WAS SIGNIFICANTLY IMPROVED.

  Patient problems: Injury

  MAUDE report 8683709 ↗
• InjuryJun 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER 6 WEEKS POST OP, PATIENT STILL DID NOT HAVE FULL FLEXION AND DECIDED TO PROCEED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 8676614 ↗
• InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A QUADRICEP TENDON RUPTURE. ACTION TAKEN: SURGERY/PROCEDURE - REVISION WITH POLY CHANGE, DEBRIDEMENT AND QUAD REPAIR.

  Patient problems: No Code Available; Rupture

  MAUDE report 7845855 ↗
• InjuryAug 31, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF TOTAL RIGHT KNEE ARTHROPLASTY. EVENT TREATMENT INCLUDED MANIPULATION UNDER ANESTHESIA.

  Patient problems: Fibrosis

  MAUDE report 7837694 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS TO RELIEVE JOINT IMMOBILIZATION.

  Patient problems: Injury

  MAUDE report 7697379 ↗
• InjuryMar 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PIN OF THE FEMUR WAS LEFT INSIDE PATIENT'S BODY.

  Patient problems: Failure of Implant

  MAUDE report 7323166 ↗

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