JOURNEY 74025621Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556422670), received between Jan 15, 2018 and Jun 1, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Degraded” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Degraded

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, ONE (1) JRNY II CR FEM OX NP LT SZ 3 AND ONE (1) JOURNEY TIBIA BASE NP LT SZ 2 EXPERIENCED SURFACE WEAR DUE TO WEAR OF ONE (1) JRNY II CR ISRT XLPE LT SZ 1-2 9MM, RESULTING IN CONTACT BETWEEN COMPONENTS. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE EXISTING PRODUCTS WILL BE REMOVED AND EXCHANGED WITH COMPETITOR DEVICES. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25354141 ↗
• InjuryOct 20, 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) 2024, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ONLY THE JRNY II CR ISRT XLPE LT SZ 1-2 9MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23343934 ↗
• InjuryJan 10, 2025Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ACCELERATED WEAR THROUGH THE ENTIRE MEDIAL SIDE OF THE BEARING IN LESS THAN ONE YEAR TIME AND WHEN REVISED IT WAS METAL ON METAL. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH DEVICE WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 21126451 ↗
• InjuryDec 23, 2023Degraded; Material Disintegration; Degraded; Material Disintegration

  IT WAS REPORTED THAT, AFTER A TKA SURGERY USING A JOURNEY SYSTEM, HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED A FALL AND DEVELOPED KNEE PAIN. ON SUBSEQUENT FOLLOW-UP, X-RAY IMAGE SHOWED CALCIFICATION AND SUSPECTED DEFORMATION OF THE MEDIAL CONDYLE OF THE FEMORAL COMPONENT OR WEAR OF THE INSERT. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2024. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement; Fall; Implant Pain; Metal Related Pathology; Swelling/ Edema

  MAUDE report 18389808 ↗
• InjuryJul 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2019 WHERE A JRNY II CR ISRT XLPE LT SZ 1-2 9MM, A JOURNEY TIBIA BASE NP LT SZ 2 AND A JRNY II CR FEM OX NP LT SZ 3 WERE IMPLANTED, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. IT WAS FOUND THAT THE INSERT SHOWED WEAR. ALL PRODUCTS WERE EXCHANGED FOR A COMPETITOR'S DEVICES. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17358440 ↗
• InjuryMay 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A FRACTURE IN THE IMPLANT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH ONE (1) JRNY II CR ISRT XLPE LT SZ 1-2 9MM WAS REPLACED WITH A S+N BACK-UP DEVICE. HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16869483 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT KNEE REPLACEMENT SURGERY PERFORMED ON (B)(6) 2017, THE IMPLANTED JRNY II CR ISRT XLPE LT SZ 1-2 9MM WAS NOTED TO BE DEFECTIVE AND WAS EXPLANTED ON (B)(6) 2023. THE PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16406339 ↗
• InjurySep 15, 2022Adverse 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 2022, PATIENT EXPERIENCED PAIN. ALSO, TIBIAL WAS EXTERNALLY ROTATED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JRNY II CR ISRT XLPE LT SZ 1-2 9MM WAS REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A COMPETITOR BACK-UP DEVICE INSTEAD. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 15426592 ↗
• InjuryJun 10, 2022Degraded; Degraded

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED SEVERE WEAR OF THE INSERT. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY TO EXPLANT THE JRNY II CR ISRT XLPE LT SZ 1-2 9MM, JRNY II CR FEM OX NP LT SZ 4, JOURNEY TIBIA BASE NP LT SZ 2 AND GEN II 7.5MM RESUR PAT 26MM. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 14655037 ↗
• InjuryJul 28, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AFTER THE SURGERY THE PATIENT FELT THE UNCOMFORTABLENESS. X-RAY SHOWED POSTERIOR SUBLUXATION OF THE FEMORAL COMPONENT. SO THE INSERT WAS REVISED.

  Patient problems: Injury

  MAUDE report 8834669 ↗
• InjuryJan 15, 2018Fitting Problem; Fitting Problem

  THE PATIENT CAME IN EXPERIENCING MID FLEXION INSTABILITY AND IT WAS DETERMINED THAT THE PATIENT COMPROMISED THE PCL. THE PATIENT HAD CR KNEE IN THERE ALREADY AND TO CORRECT THE PROBLEM WE PUT IN A DISHED CR INSERT

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7190819 ↗

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