NA 74033634Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010672063), received between Dec 20, 2020 and Mar 29, 2023 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED, THAT DURING A TKA SURGERY, WHILE TRIALING THE INSERT, THE EDGE OF THE UNIV ISRT SPACER SZ3-4 13M WAS BROKEN OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635146 ↗
• MalfunctionDec 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A UNIV ISRT SPACER SZ3-4 13M BROKE WHILE TESTING/TRIALING THE SPACE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956535 ↗
• MalfunctionJul 7, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A UNIVERSAL INSERT SPACER SIZE 3-4 13MM CRACKED. SURGERY WAS RESUMED WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952065 ↗
• InjurySep 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO (2) UNIV ISRT SPACER SZ3-4 13M BROKE OFF. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITH A DELAY LESS THAN OR EQUAL TO 30 MIN. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538291 ↗
• InjurySep 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO (2) UNIV ISRT SPACER SZ3-4 13M BROKE OFF. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITH A DELAY LESS THAN OR EQUAL TO 30 MIN. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538289 ↗
• InjurySep 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A UNIV ISRT SPACER SZ3-4 13M BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538242 ↗
• MalfunctionMay 20, 2021Crack; Crack

  IT WAS REPORTED THAT A G2 INS SPAC TR SZ3-4 13MM WAS CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853505 ↗
• InjuryFeb 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE DEVICE WAS BROKEN WHILE TRIALING. NO DELAY. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356675 ↗
• MalfunctionFeb 8, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKE IN HALF. NO PATIENT INVOLVED IN THE CASE. 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 11291290 ↗
• MalfunctionDec 20, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICES WERE FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11043117 ↗

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