JOURNEY 74012576Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556001042), received between Feb 4, 2020 and Feb 5, 2026 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THERE WAS A LITTLE SCREW IN THE TOP WINDOW OF ONE (1) JRN II BCS BOX PREP GD SZ6-8 THAT WAS DAMAGED AND SITTING PROUD. IT WAS PREVENTING THE BOX CHISEL FROM PASSING THROUGH THAT SPACE SMOOTHLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268308 ↗
• InjurySep 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2025, A POST OPERATIVE X-RAY REVEALED THAT ONE OF THE SCREWS AT THE HINGE OF ONE (1) JRN II BCS BOX PREP GD SZ6-8 HAD BECOME LOOSE AND SLID OUT OF PLACE DURING THE REMOVAL OF THE GUIDE. AS A RESULT, THE LOOSE SCREW WAS INADVERTENTLY LEFT INSIDE THE PATIENT¿S KNEE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON THE SAME DAY TO REMOVE THE SCREW. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23185804 ↗
• MalfunctionApr 11, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TKA SURGERY, IT WAS NOTICED THAT ONE (1) JRN II BCS BOX PREP GD SZ6-8 WAS DAMAGED AND WILL NOT ALLOW BOX CHISEL TO GO THROUGH AS DESIGNED. THERE SEEMS TO BE SOME KIND OF SCREW INTERNALLY LOOSE THAT MAY BE STRIPPED AND IS POKING OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087289 ↗
• MalfunctionAug 28, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE METAL OF THE JOURNEY II BCS FEMORAL BOX PREP GUIDE SZ 6-8 IS WORN AND CHIPPED NEAR SCREW HOLES, ALSO, THE LETTERING OF THE SPECIFYING SIZE CAN NO LONGER BE SEEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307929 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A JOURNEY II BCS FEMORAL BOX PREP GUIDE SIZE 6-8 BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472048 ↗
• MalfunctionJul 5, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE OF THE RIVETS OF THE JRN II BCS BOX PREP GD SZ6-8 WAS DISLODGED. THIS HAPPENED AFTER USE IN PATIENT; THEREFORE, NO PIECE FELL INSIDE OF THE PATIENT. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114796 ↗
• InjuryMay 13, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JRN II BCS BOX PREP GD SZ6-8 WAS USED TO PREPARE THE FEMUR FOR A 6 BCS FEMORAL TRIAL. IT WAS NOTICED THAT NOT SUFFICIENT BONE WAS REMOVED, AS THE CAM TRIAL WAS UNABLE TO FIT DOWN. SURGEON USED A SAW TO REMOVE AN ADDITIONAL 2MM OF BONE TO ALLOW THE CAM TRAIL TO FIT. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820008 ↗
• InjuryFeb 25, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE WHEN THE SURGEON FINISHED THE PS BOX PREP, THEY REMOVED THE INSTRUMENTS IN QUESTION AND REALIZED THAT THERE WERE SCREWS / SPRINGS ENDED UP LOOSE IN THE PATIENT. THEY RETRIEVED LOOSE PARTS WITHOUT ANY PROBLEM. THIS DID NOT CAUSE ANY DELAYS WHATSOEVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382582 ↗
• InjuryFeb 22, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE A JOURNEY II BCS BOX PREP GD SIZE 6-8 ARE EXTREMELY WORN, AND METAL SHAVING'S WERE GETTING ON PATIENT. INSTRUMENTS WERE INSIDE THE PATIENT AND THERE WAS A TECHNIQUE CHANGE FOR COMPLETING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11357023 ↗
• InjuryFeb 22, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE A JOURNEY II BCS BOX PREP GD SIZE 6-8 ARE EXTREMELY WORN, AND METAL SHAVING'S WERE GETTING ON PATIENT. INSTRUMENTS WERE INSIDE THE PATIENT AND THERE WAS A TECHNIQUE CHANGE FOR COMPLETING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11357021 ↗
• InjuryFeb 22, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE A JOURNEY II BCS BOX PREP GD SIZE 6-8 ARE EXTREMELY WORN, AND METAL SHAVING'S WERE GETTING ON PATIENT. INSTRUMENTS WERE INSIDE THE PATIENT AND THERE WAS A TECHNIQUE CHANGE FOR COMPLETING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357019 ↗
• InjuryJan 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHEN PERFORMING THE SECOND BOX CHISEL CUT, THE BOX CHISEL GOT STUCK IN THE JRN II BCS BOX PREP GD SZ6-8. IT IS STRUCK. THIS HAPPENED INSIDE THE PATIENT, AND A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED. THERE WAS NO DELAY AND NO HARM TO THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED. 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 11242861 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY AN EMPLOYEE OF (B)(6) HOSPITAL IN THE CENTRAL STERILIZATION DEPARTMENT INJURED THEMSELVES DUE TO A BURR FOUND ON THE JOURNEY II BCS BOX PREP GUIDE SIZE 6-8. THE DEVICE WAS STUCK IN EMPLOYEE´S FINGER BY A METAL SHAVING STICKING OFF OF THE INSTRUMENT.

  Patient problems: Injury

  MAUDE report 9664321 ↗

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