JOURNEY 74025631Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556422601), received between Nov 30, 2017 and Jun 13, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN THE BOX OF ONE (1) JRNY II CR ISRT XLPE RT SZ 3-4 9MM WAS OPENED, IT WAS REALIZED THAT BOTH STERILE PACKAGING OF THE POLY HAD BEEN OPENED. IT COULD BE A MANUFACTURING DEFECT, OR IT COULD BE CAUSED BY THE WAY IT WAS STORED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING AN S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532359 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2019 AND WAS UNABLE TO REHAB. SYNOVECTOMY WAS PERFORMED AND THE INSERT WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912851 ↗
• InjuryJun 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A ORTHOPEDIC SURGERY HAD TO BE PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE. REHABILITATION THERAPY FOLLOWING THE TKA WITH JOURNEY II CR TKS WAS PERFORMED ON (B)(6) 2016.

  Patient problems: Injury

  MAUDE report 10141408 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED CELLULITIS IN THE RIGHT LOWER EXTREMITY. THE EVENT WAS TREATED VIA MEDICATION AND MEDICAL INTERVENTION TO PREVENT A LIFE-THREATENING CONDITION IN THE SUBJECT

  Patient problems: Unspecified Infection

  MAUDE report 9842192 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE ARTHROFIBROSIS AFTER A TKR. THE EVENT WAS RESOLVED VIA MUA, WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9832149 ↗
• InjurySep 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED A RIGHT FOOT FRACTURE. ADVERSE EVENT HAS A POSSIBLE RELATION TO DEVICE. NO PROCEDURE DETAILS REPORTED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8969154 ↗
• InjuryAug 7, 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 8868017 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  A JOURNEY CR RIGHT 9MM INSERT WAS EXCHANGED FOR A JOURNEY RIGHT CR 15 MM DEEP DISHED INSERT FOR MORE STABILIZATION. THE PCL WAS ALSO COMPROMISED.

  Patient problems: No Information

  MAUDE report 7073523 ↗

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