JOURNEY 74035783Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556534359), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING AN INSERT EXCHANGE IN A CR KNEE, A SIZE 7/8 11MM DEEP DISHED INSERT DID NOT LOCK IN AFTER SEVERAL TRIES. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAYS AND NO INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479625 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A KNEE SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A REVISION SURGERY TO EXCHANGE THE DISH IN THE CR KNEE. THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11479557 ↗