JOURNEY 74012456Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03596010672049), received between Feb 6, 2019 and Jul 7, 2022 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER TKA SURGERY, THE ROTATIONAL STABILITY ON THE JRNY II TKA FEM SIZING GDE RT LOOSE. AS THIS WAS AFTER THE SURGERY, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952075 ↗
• MalfunctionMay 31, 2021Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, THE JOURNEY II TKA FEM SIZING GDE RIGHT DID NOT LOCK IN PLACE AFTER ADJUSTMENT. THERE WAS NO SIGNIFICANT DELAY 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 11909323 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE EXTERNAL ROTATION KNOB OF A JRNY II TKA FEM SIZING GDE RT IS LOOSE AND NOT WORKING. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809251 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE JRNY II TKA FEM SIZING GDE RT WAS NOT FUNCTIONING PROPERLY, IT WAS FOUND TO BE BROKEN WHILE USING IN PATIENT. WHEN DIALING THE ROTATION IT DID NOT SET TO 0 DEGREES. THE DEVICE WAS NOTICED TO BE BROKEN BUT IS ALL IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH A LESS THAN 30 MINS DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695328 ↗
• MalfunctionApr 18, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY II TKA FEM SIZING GDE RT WAS UNABLE TO DIAL TO ZERO DEGREES. NO SIGNIFICANT SURGERY DELAY WAS REPORTED (1 MINUTE), AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. DESPITE PATIENT WAS INVOLVED, NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683567 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, A JOURNEY II TKA FEM SIZING GDE RIGHT WAS VERY LOOSE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683536 ↗
• MalfunctionApr 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, THE ADJUSTMENT KNOB ON SIZER IS LOOSE FROM USE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655874 ↗
• MalfunctionMar 8, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE ANTERIOR/POSTERIOR SHIFTING HOLE OF A RIGHT JOURNEY II TKA FEM SIZING GDE WILL NOT LOCK. INSTRUMENTS WERE OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO DELAY OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431006 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE RIGHT 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 11356759 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE RIGHT 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 11356758 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE RIGHT 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 11356757 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE RIGHT 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 11356756 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE RIGHT 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 11356755 ↗
• MalfunctionFeb 21, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II TKA FEM SIZING GDE RIGHT 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 11356753 ↗
• MalfunctionJan 18, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY BOTH OF THE SIZE GUIDES ARE TOO LOOSE AND NEED TO BE REPLACED. NO INJURY. NO DELAY. S+N BACKUP AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189668 ↗
• MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE KNOB ON THE SIZING GUIDE IS LOOSE AND WILL NOT STAY IN PLACE WHEN ADJUSTING THE EXTERNAL ROTATION. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055911 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SET SCREW ON THE FEMORAL SIZING GUIDE BROKE IN AND IT SLID WHILE BEING PINNED IN PLACE. SURGEON CAUGHT IT AND NO HARM WAS DONE TO THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE; HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788650 ↗
• MalfunctionNov 2, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA, THE KNOB AT THE BOTTOM OF THE JRNY II TKA FEM SIZING GDE RT WAS LOOSE, DID NOT STAY IN PLACE. SURGERY WAS COMPLETED AS SCHEDULED FOR THERE WAS A BACK-UP DEVICE AVAILABLE. PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771563 ↗
• MalfunctionOct 22, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE SURGEON COMPLAINED THAT THIS SIZING GUIDE IS TOO LOOSE. SMITH AND NEPHEW BACKUP DEVICE AVAILABLE BUT WAS NOT NECESSARY. THERE WAS A DELAY OF 1 TO 2 MINUTES. NO HARM TO THE PATIENT REPORTED. NO ADVERSE AFFECTS OF ANY KIND HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10719063 ↗
• MalfunctionSep 7, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE KNOB IN THE JRNY II TKA FEM SIZING GDE RT SPINS WHEN SIZE IS SQUEEZED AND THE HOLE FOR STYLUS IS TOO TIGHT. PIECE IS PUSHING IN. IT IS UNKNOWN WHEN THIS WAS DISCOVERED OR IF THERE WAS 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; No Known Impact Or Consequence To Patient

  MAUDE report 10500260 ↗
• MalfunctionJul 23, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING TKA SURGERY THE JRNY II TKA FEM SIZING GDE RT WAS FOUND WITH EXTERNAL ROTATION NUMBERS BEING HARD TO READ. ITS PIN IS LOOSE. NO DELAY. PROCEDURE WAS FINISHED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312903 ↗
• MalfunctionJun 25, 2020Connection Problem; Device Dislodged or Dislocated; Connection Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE KNOB ON A JOURNEY II TKA FEMORAL SIZING GUIDE RIGHT IS VERY LOOSE, THEREFORE THE DEVICE NEEDS REPLACEMENT. EVENT HAPPENED DURING SET UP OR INSPECTION. 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; No Patient Involvement

  MAUDE report 10196802 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT DURING THE CASE THE DEVICE GOT BROKEN. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING AN S&N BACK-UP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451293 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, SURGEON NOTICED THAT THE SCREW WAS STRIPPED. NO DELAY, NO BACKUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310696 ↗

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