NA 74033675Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010671837), received between Feb 22, 2019 and Dec 31, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K111711); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION IT WAS NOTICED THAT THE UNIV INSERT SPACER SIZE 7-8 15MM, WAS CRACKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11099625 ↗
• MalfunctionAug 18, 2020Crack; Crack

  IT WAS REPORTED THAT DURING PROCEDURE TKA, THE SPACER WAS CRACKED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND WITH THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10422925 ↗
• MalfunctionFeb 22, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSTRUMENT BROKE WHILE TRIALING. UNKNOWN IF THERE WAS A DELAY OR A BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362236 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5