JOURNEY 74035261Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556157039), received between Apr 9, 2019 and Sep 1, 2022 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 5-6 9MM LT WAS DISCOVERED BROKEN AFTER CLEANING BY THE SPD WHEN THE SET WAS BEING PUT BACK TOGETHER. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341726 ↗
• InjurySep 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JRNY II BCS ART ISRT TRL SZ 5-6 9MM LT (B)(4) AND A JOURNEY II TIBIA INSERT IMPACTOR (B)(4) BROKE AFTER THE PHYSICIAN HIT THEM WITH A MALLET BECAUSE HE WAS TRYING TO INSERT THE TRIAL POLY INTO THE JOURNEY II TIBIA IMPLANT WHILE THE CEMENT HARDENED. THE INCIDENT ADDED ABOUT A MINUTE ONTO THE SURGERY, UNTIL THE PHYSICIAN REMOVED THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED USING THE SAME TRIAL BROKEN POLY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339412 ↗
• MalfunctionMay 20, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, WHILE CLEANING, IT WAS NOTICED THAT THE JRNY II BCS ART ISRT TRL SZ 5-6 9MM LT HAS CHIPS AND DENTS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462759 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE JRNY II BCS ART ISRT TRL SZ 5-6 9MM LT WAS CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861027 ↗
• MalfunctionOct 13, 2021Crack; Crack

  IT WAS REPORTED DURING INSPECTION THAT THE BOTTOM OF A JRNY II BCS ART ISRT TRL SZ 5-6 9MM LT IS CRACKED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623852 ↗
• InjuryJul 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A JOURNEY II BCS ART INSERT TRIAL SIZE 5-6 9MM LEFT BROKE INSIDE THE PATIENT DURING TRIALING. ALL PIECES WERE RECOVERED AND THE PROCEDURE WAS FINISHED WITHOUT DELAYS USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144631 ↗
• MalfunctionApr 11, 2021Break; Break

  IT WAS REPORTED THAT, FOR A JRNY II BCS ART ISRT TRL SZ 5-6 9 MM LT, THE TRIAL NEEDS TO BE REPLACED, IT HAS PARTS CHIPPED AND IT'S UNUSABLE. 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 11646849 ↗
• InjuryJan 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT BROKE WHEN TRIALING. PROCEDURE CONTINUED WITH A CHANGE IN TECHNIQUE AND WITHOUT A DELAY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229778 ↗
• InjuryDec 30, 2020Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE, WHILE INSIDE PATIENT, WAS NOTED THAT THE JOURNEY II BCS ART INSERT TRIAL SIZE 5-6 9MM LEFT WAS CHIPPED AND NOT LOCKING PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH & NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094552 ↗
• MalfunctionSep 29, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE JOURNEY II BCS ART INSERT TRIAL SIZE 5-6 9MM LEFT BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602834 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH GOUGES/CRACKS/SCRATCHES. NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10322090 ↗
• MalfunctionMay 29, 2020Crack; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF A LOANER KIT IN WAREHOUSE THE PART WAS FOUND BROKEN/ MISSING/ DEFORMED. THE DEVICE WILL NOT BE RETURNED. THERE WAS NO HARM TO PATIENT, NO DELAY, AND THE BROKEN PIECE WAS NOT REMAIN. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102522 ↗
• MalfunctionMay 29, 2020Crack; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF A LOANER KIT IN WAREHOUSE THE PART WAS FOUND BROKEN/ MISSING/ DEFORMED. THE DEVICE WILL NOT BE RETURNED. THERE WAS NO HARM TO PATIENT, NO DELAY, AND THE BROKEN PIECE WAS NOT REMAIN. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101922 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED THAT DURING TKA THE POLY BROKE ON MEDIAL CONCAVE SIDE. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497550 ↗

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