JOURNEY 74035224Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556156834), received between Dec 10, 2020 and Sep 17, 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.

• 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 12487997 ↗
• 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 12487985 ↗
• MalfunctionApr 18, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION IN WAREHOUSE THE DEVICES WERE FOUND DEFECTIVES. THE TIBIAL SPACER BLOCK STANDAR WAS NOTICED WITH AN UNSPECIFIC FAILURE MODE (B)(4). THE JOURNEY FEMORAL IMPLANT IMPACTOR BUMPER RIGHT (B)(4) WAS NOTICED BROKEN. THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4), UNIVERSAL INSERT SPACER SIZE 1-2 18 MM (B)(4), JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 8 MM (B)(4), UNIVERSAL INSERT SPACER SIZE 1-2 13 MM (B)(4) AND JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 9 MM (B)(4) WERE NOTICED CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683540 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT ((B)(4), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT ((B)(4)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM ((B)(4)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT ((B)(4)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM ((B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM ((B)(4)),JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM ((B)(4)), THREE HONEYCOMB ((B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT ((B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT ((B)(4)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT ((B)(4)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER ((B)(4)) AND SCREWDRIVER RELEASE HANDLE ((B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593418 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT, FOR A JOURNEY II BCS ART INSERT TRIAL SIZE 1-2 12MM LEFT, THE INSERT WAS CHIPPED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10982845 ↗

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