JOURNEY 74033615Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010671899), received between Jul 23, 2020 and May 12, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA, THE UNIV ISRT SPACER BROKE. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14385613 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487945 ↗
• InjuryApr 5, 2021Break; Break

  IT WAS REPORTED THAT, THE DURING A TKR THE UNIV ISRT SPACER SZ1-2 15M BROKE IN HALF. INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612123 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047048 ↗
• MalfunctionDec 21, 2020Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047026 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED THAT THE UNIV ISRT SPACER SZ1-2 15M WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10318282 ↗

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-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; 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