JOURNEY 74035251Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556157633), received between Dec 21, 2020 and Jul 17, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BACK LOCKING MECHANISM OF THE JRNY II BCS ART ISRT TRL SZ 5-6 9MM RT BROKE OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759317 ↗
• MalfunctionOct 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II BCS ART ISRT TRL SZ 5-6 9MM RT BROKE IN HALF AFTER IT WASN'T GOING DOWN ALL THE WAY, AND IT WAS IMPACTED WITH A MALLET AND A RAMP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860911 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 5-6 9MM RT IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287128 ↗
• 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 12488047 ↗
• MalfunctionAug 6, 2021Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II BCS ART ISRT TRL SZ 5-6 9MM RT WAS WORN OUT. IN ADDITION, IT HAD CHIPS AND SCARRING FROM USE. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY. HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291739 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A FIELD INSPECTION, A JOURNEY II BCS ART INSERT TRIAL SIZE 5-6 9MM RIGHT WAS FOUND BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135832 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. IT WAS NOTICED THAT THE NAIL PROX DROP (B)(4) HAS A DEFECTIVE ATTACHMENT. FOUR GENESIS II TIBIAL ALIGNMENT SPIKED FIXATION ROD (B)(4), THE SCREWDRIVER RELEASE HANDLE (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM RIGHT (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 5-6 9MM LEFT (B)(4), R3 0 DEG 32 MM TRIAL 48 MM (B)(4), THE HONEYCOMB (B)(4), THE BOX CHISEL (B)(4), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11 MM RIGHT (B)(4), THE LAG SCREW 3.2 GUIDE PIN SLEEVE (B)(4), THE MEDIUM HEXDRIVER (B)(4), THE SUBTROC LAG SCREW DRIVER (B)(4), THE ACCORD DUAL ENDED HEX DRIVER (B)(4) TWO THIN OSTEO BLADE 8X3 (B)(4), THE THIN OSTEO BLADE 12X3 (B)(4) AND THE JOURNEY DCF AP FEM CUT BLK 4 (B)(4) WERE NOTICED CRACKED. THE NAIL PROX DROP (B)(4), THE META ANTERIOR DROP (B)(4), THE MI Z HANDLE ACET REAMER (B)(4) AND TWO THIN OSTEO BLADE 8X3 (B)(4) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593372 ↗
• 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 11048271 ↗

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