NA 74033635Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010671882), received between Apr 6, 2021 and Dec 27, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2021Crack; Crack

  IT WAS REPORTED THAT A UNIVERSAL INSERT SPACER SIZE 3-4 15MM WAS NOTICED TO BE CRACKED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087651 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, TWO (2) UNIVERSAL INSERT SPACER SIZE 3-4 15MM BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920171 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, TWO (2) UNIVERSAL INSERT SPACER SIZE 3-4 15 MM BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920134 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP/INSPECTION FOR TKA THE UNIV ISRT SPACER SZ3-4 15M WAS FOUND TO BE BROKEN. THERE WAS NO DELAY IN SURGERY AND IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742485 ↗
• MalfunctionApr 6, 2021Crack; Crack

  IT WAS REPORTED THAT, UPON INSPECTIONS OF INSTRUMENTS WAS NOTICED A CRACK IN THE UNIV ISRT SPACER SZ3-4 15M. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617573 ↗

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