NA 74033654Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010671875), received between Aug 6, 2021 and Dec 22, 2025 — classified as 6 malfunctions.

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

• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIECE OF PLASTIC OF THE UNIV ISRT SPACER SZ5-6 13M, BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871497 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN REMOVING THE TRIAL POLY, A PIECE OF THE UNIV ISRT SPACER SZ5-6 13M BROKE OFF AND WAS NOTICED BY SITTING ON THE TIBIA TRIAL. ON THE POSTERIOR ASPECT OF THE 13MM SHIM, A CRACK IN THE PLASTIC WAS NOTICED. ALL REMAINING PIECES OF THE BROKEN SHIM WERE REMOVED FROM THE TRIAL TIBIA AND FROM WITHIN THE INCISION. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY OR INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644351 ↗
• MalfunctionMar 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) UNIV ISRT SPACER SZ5-6 13M BROKE. IN ADDITION, NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570452 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT THE UNIV ISRT SPACER SZ5-6 13M BROKE DURING TKA SURGERY. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478788 ↗
• MalfunctionDec 3, 2021Crack; Crack

  IT WAS REPORTED THAT THESE INSERT TRIALS AND SPACERS ARE CRACKED: GII PS HI FLEX ISRT TR S5-6 11, UNIV ISRT SPACER SZ5-6 13M, UNIV ISRT SPACER SZ 5-6 15MM, GII CR DEEP FLX ISR TR S5-6 9, AND GII CR DEEP FLX ISR TR S5-6 11. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924822 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT DURING, A SET UP AND INSPECTION A UNIV ISRT SPACER SZ5-6 13M WAS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291748 ↗

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