JOURNEY 74033641Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556421925), received between Mar 13, 2019 and Jul 1, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II CR ISRT TRL LT SZ 3-4 9M BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643952 ↗
• InjuryApr 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A JRNY II CR ISRT TRL LT SZ 3-4 9M BROKE IN HALF DURING IMPACTION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722105 ↗
• MalfunctionOct 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING TKA PROCEDURE WHILE THE INSTRUMENT WAS OUTSIDE THE PATIENT, THE BOTTOM OF THE JOURNEY II CR INSERT TRIAL LEFT SIZE 3-4 9M IS CHIPPED FORM USE. NOTHING FELL INTO PATIENT, NO DELAY TO PROCEDURE, NO HARM TO PATIENT, ALL PIECES RECOVERED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10682677 ↗
• MalfunctionJun 18, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL WAS BROKEN. I WAS NOTICED BEFORE IT WAS USED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10167159 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, DEVICE BROKE DURING IMPACTION. IT IS UNKNOWN IF THERE WAS A DELAY, AN INJURY OR HOW WAS THE SURGERY CONCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8471178 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ITEM BROKE DURING IMPACTION. NO DELAY WAS REPORTED AND IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417116 ↗