JOURNEY 74012455Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 03596010672087), received between Aug 29, 2018 and Jun 23, 2021 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II TKA FEM SIZING GDE LEFT AND ONE (1) GII QUICK CONNECT HANDLE BROKE DURING SURGERY, INSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH BACKUP DEVICES INSTEAD, WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051797 ↗
• MalfunctionJun 1, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON MENTIONED THAT, THE KNOB ON THE JRNY II TKA FEM SIZING GDE LT IS LOOSE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916572 ↗
• MalfunctionMay 27, 2021Loose or Intermittent Connection; Mechanics Altered; Loose or Intermittent Connection; Mechanics Altered

  IT WAS REPORTED THAT DURING A SET UP FOR A TKA, IT WAS NOTICED THAT THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE AND WOULDN'T LOCK DOWN. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896025 ↗
• MalfunctionMay 13, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE ROTATION CONTROL DIAL OF A JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE AND WOULD NOT STAY IN PLACE. THERE WAS A DELAY OF FEWER THAN 30 MINUTES AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816895 ↗
• MalfunctionMay 13, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE ROTATION CONTROL DIAL OF A JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE AND WOULD NOT STAY IN PLACE. THERE WAS A DELAY OF FEWER THAN 30 MINUTES AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816883 ↗
• MalfunctionMay 12, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE FRONT SCREW OF A JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813791 ↗
• MalfunctionMay 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE JRNY II TKA FEM SIZING GDE LT ROTATION SCREW WAS LOOSE AND CAN¿T TRUST THE ROTATION OF THE FEMORAL COMPONENT WITH IT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781332 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY II TKA FEM SIZING GDE LEFT WILL NOT STAY LOCKED IN ROTATION. THE EVENT OCCURRED DURING USE AND INSTRUMENTS WERE INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683566 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA, A JRNY II TKA FEM SIZING GDE LT DID NOT STAY LOCKED IN ROTATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683565 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING TKA SURGERY, WHILE THE JOURNEY II TKA FEMORAL SIZING GUIDE LEFT WAS INSIDE THE PATIENT, THE DEVICE DID NOT STAY LOCKED IN ROTATION. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683564 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA, A JRNY II TKA FEM SIZING GDE LT DID NOT STAY LOCKED IN ROTATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683562 ↗
• MalfunctionApr 18, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A JRNY II TKA FEM SIZING GDE LT WOULD NOT LOCK IN ROTATION. THE PROCEDURE WAS SUCCESSFULLY 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 11683534 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING TKA SURGERY THE JRNY II TKA FEM SIZING GDE LT WOULD NOT STAY LOCKED ON ROTATION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683533 ↗
• MalfunctionApr 15, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, WHILE SETTING UP FOR A TKA PROCEDURE, THE ITEM WAS NOTICED TO BE LOOSE AND WOULD NOT WORK PROPERLY. A BACK UP S&N ITEM WAS AVAILABLE, THERE WAS NO DELAY AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671481 ↗
• MalfunctionMar 10, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING INSPECTION OF THE KIT NO. 008794-036-S002, THE JOURNEY II TKA FEM SIZING GDE LEFT DIDN'T LOCK DOWN LIKE IT'S SUPPOSED TO. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449815 ↗
• MalfunctionMar 5, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, WAS NOTICED THAT THE VALGUS ADJUSTMENT ON THE JOURNEY II TKA FEMORAL SIZING GUIDE LT WAS LOOSE. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419349 ↗
• MalfunctionMar 3, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, WAS NOTICED THAT THE VALGUS ADJUSTMENT ON THE JOURNEY II TKA FEMORAL SIZING GUIDE LT WAS LOOSE. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408593 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. NO DELAYS, NOR INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356754 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. NO DELAYS, NOR INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356752 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. NO DELAYS, NOR INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356751 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. NO DELAYS, NOR INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356750 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. NO DELAYS, NOR INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356749 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE LEFT WAS LOOSE. NO DELAYS, NOR INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356747 ↗
• MalfunctionJan 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE JOURNEY II TKA FEM SIZING GDE LEFT IS NOT STAYING ON 3 DEGREE MARK. PROBLEM WAS NOTICED DURING A CASE. NO INJURY TO THE PATIENT OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240732 ↗
• MalfunctionJan 27, 2021Crack; Crack

  IT WAS REPORTED THAT THE JRNY II TKA FEM SIZING GDE LT IS CHIPPED AND CRACKED. INCIDENT OCCURRED DURING A STANDARD OFFICE EFIP INSPECTION. 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 11234620 ↗

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