JOURNEY 74021165Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00885556422786), received between Sep 11, 2018 and Nov 10, 2025 — classified as 23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER A PRIMARY TKA SURGERY PERFORMED ON (B)(6) 2025, CT IMAGING REVEALED THE ABSENCE OF THE MEDIAL PEG IN THE JRNY II CR FEM OX NP LT SZ 5. SUBSEQUENTLY, THE PEG WAS FOUND OUTSIDE THE PATIENT¿S BODY (IN THE OPERATING ROOM), LEADING TO THE CONCLUSION THAT IT HAD BECOME DISLODGED DURING THE PRIMARY SURGERY. IT REMAINS UNKNOWN HOW THIS INCIDENT WAS RESOLVED, AS THE REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23511606 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: NEW JOURNEY II CR STUDY ID: (B)(6) SUBJECT: (B)(6) AE: 8. IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2016, THE PATIENT STARTED EXPERIENCING, ON (B)(6) 2021, AN INTERMITTENT ACHINESS OF THE LEFT KNEE AT NIGHT; THESE EVENTS HAVE BEEN REPORTED TO BE OF MILD SEVERITY. IT IS UNKNOWN IF THE PATIENT HAS BEEN GIVEN ANY TREATMENTS, INTERVENTIONS OR MEDICATIONS TO TREAT THIS ADVERSE EVENT. THE PATIENT'S CONDITIONS HAVE BEEN REPORTED AS UNRESOLVED.

  Patient problems: Arthralgia

  MAUDE report 18192558 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 6 WEEKS AFTER A TKA WITH A JOURNEY II CR KNEE SYSTEM, ON (B)(6) 2022, PATIENT EXPERIENCED A FLEXION AND EXTENSION CONTRACTURE, ROM 82/20/20 . PATIENT WAS HOSPITALIZED FOR A MANIPULATION UNDER ANESTHESIA OF THE KNEE ON (B)(6) 2022 AND WENT UNEVENTFUL. PATIENT STARTED REHABILITATION RIGHT AFTER AND IS STILL RECOVERING.

  Patient problems: Bacterial Infection; Joint Contracture; Loss of Range of Motion

  MAUDE report 15540383 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 6 WEEKS AFTER A TKA WITH A JOURNEY II CR KNEE SYSTEM, ON (B)(6) 2022, PATIENT EXPERIENCED A FLEXION CONTRACTURE, ROM 95/5/0. THIS WAS ADDRESS WITH A MANIPULATION UNDER ANESTHESIA ON (B)(6) 2022, A ROM OF 130/0/0 WAS ACHIEVED. PATIENT IS STILL RECOVERING.

  Patient problems: Joint Contracture

  MAUDE report 15519463 ↗
• InjuryJan 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13212522 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL LEFT KNEE ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2017, AN INCISION DRAINAGE WAS PERFORMED ON (B)(6) 2017. PATIENT'S SYMPTOMS/MEDICAL CONDITIONS EXPERIENCED PREVIOUS TO THE DRAINAGE ARE UNKNOWN. THE ISSUE WAS RESOLVED WITH THIS MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 12537805 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO LEFT KNEE PAIN AND STIFFNESS. THIS ISSUE WAS RESOLVED. FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion

  MAUDE report 12513108 ↗
• InjurySep 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A PATELLA INSTABILITY IN THE LEFT KNEE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2018. PATIENT OUTCOME AS BEEN RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 12511127 ↗
• InjuryMay 28, 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 (B)(6) 2016, THE CLINICAL SUBJECT EXPERIENCED ASEPTIC LOOSENING OF KNEE PROSTHESIS THAT ENDED UP BEEN TREATED WITH A LEFT KNEE REVISION SURGERY ON (B)(6) 2020. THE ISSUE WAS RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 11902245 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INVESTIGATION STUDY OF JOURNEY II CR, THE PATIENT PRESENT A LEFT KNEE STITCH ABSCESS. THE PATIENT WAS MEDICATED. THE PATIENT'S PROBLEM WAS RESOLVED . NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Abscess

  MAUDE report 10775156 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS ADDRESSED BY PERFORMING A REVISION SURGERY: ALL COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10766977 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED LEFT KNEE HEMARTHROSIS AND CELLULITIS. THE EVENT WAS RESOLVED VIA REVISION SURGERY. THE EVENT IS CONSIDERED ONGOING.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9997464 ↗
• InjuryApr 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT HAD BEEN EXPERIENCING PROBLEMS ASSOCIATED WITH STIFFNESS ON HIS SURGERY KNEE. THE SUBJECT ATTEMPTED PHYSICAL THERAPY BUT ENDED UP DEVELOPING ARTHROFIBROSIS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND ITS OUTCOME IS CONSIDERED UNKNOWN.

  Patient problems: Injury

  MAUDE report 9978070 ↗
• InjuryApr 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED STIFFNESS OF LEFT KNEE. EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9951763 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED STIFFNESS ON LEFT KNEE. EVENT TREATED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9937786 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM SCAR TISSUE DEBRIDEMENT ON THE LEFT KNEE. THE EVENT WAS TREATED VIA ARTHROSCOPY AND WAS RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9901045 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STITCH ABCESS IN THE DISTAL END OF HER LEFT KNEE INCISION. IT WAS TREATED WITH ANTIBIOTICS AND SURGERY FOR INCISION AND DRAINAGE. THE WOUND HAD DELAYED HEALING WITH CONTINUED ANTIBIOTICS AND BETADINE TREATMENTS.

  Patient problems: Injury

  MAUDE report 9281428 ↗
• 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 8864208 ↗
• InjuryJun 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CLOSED MANIPULATION UNDER ANESTHESIA HAS BEEN DONE DUE TO STIFFNESS IN THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8746835 ↗
• InjuryFeb 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A XR TOTAL KNEE DUE TO ASEPTIC LOOSENING OF COMPONENTS.

  Patient problems: Injury

  MAUDE report 8334111 ↗
• InjuryNov 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAS COMPLAINED OF PAIN IN THE KNEE SINCE THE INITIAL PROCEDURE. REVISION SURGERY WAS PERFORMED. NO DELAY, ADDITIONAL INJURIES OR BACK UP REPORTED.

  Patient problems: Injury; Pain

  MAUDE report 8030437 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 7931240 ↗
• InjurySep 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED FOR A PATIENT DUE TO A FRACTURE OF THE MEDIAL ASPECT OF LEFT PROXIMAL TIBIAL METAPHYSIS.

  Patient problems: Injury

  MAUDE report 7865089 ↗

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