JOURNEY 74012575Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556000991), received between Mar 22, 2019 and Apr 20, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, WHEN THE SURGEON WAS PLACING A JII BCS INSERT TRIAL 1-2 10MM RIGHT ON THE BASE PLATE, IT CHIPPED OFF. ADDITIONALLY, ONE OF THE RIVETS OF A JRN II BCS BOX PREP GD SZ3-5 CAME DISSOCIATED FROM THE HINGE. ALL PIECES WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933570 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE OF THE SIDE SCREWS OF ONE (1) JRN II BCS BOX PREP GD SZ3-5 CAME OUT WHEN IMPACTED IT DOWN, SO THE WHOLE DEVICE FELL APART. IT ABLE TO KEEP IT TOGETHER AND HOLD IT ON TO COMPLETE THE BOX PREP WITH THE BROKEN INSTRUMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310518 ↗
• MalfunctionAug 28, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE METAL OF THE JOURNEY II BCS FEMORAL BOX PREP GUIDE SIZE 3-5 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 NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307931 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE JRN II BCS BOX PREP GD SZ3-5 BROKE. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450516 ↗
• MalfunctionMay 31, 2021Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  IT WAS REPORTED THAT DURING AND INSPECTION, IT WAS NOTICED THAT THE JOURNEY II BCS BOX PREP GD SIZE 3-5 WAS OLD AND WORN OUT, WITH METAL THINNING AND CHIPPING OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907607 ↗
• MalfunctionMay 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, IT WAS NOTICED THAT THE SCREW HOLES DIRECTLY BEHIND PART OF THE JRN II BCS BOX PREP GD SZ3-5, WHERE MAT & BATCH ARE NOTATED, HAS SOME KIND OF RED SUBSTANCE WORKED INTO THE SCREW HOLES. HOSPITAL STAFF WERE UNABLE TO GET IT REMOVED AFTER SEVERAL PASSES THROUGH STERILIZER. STAFF WERE CONCERNED THIS POSED A BIOHAZARD. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880925 ↗
• InjuryFeb 22, 2021Naturally Worn; Sharp Edges; Naturally Worn; Sharp Edges

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THREE JOURNEY II BCS BOX PREP GD SIZE 3-5 ARE WORN DOWN LEAVING METAL SHAVINGS IN PATIENT. ALSO SHARP AND JAGGED FROM EXCESSIVE USE. THERE WAS A TECHNIQUE CHANGE FOR COMPLETING THE PROCEDURE. INSTRUMENTS INSIDE THE PATIENT. NO DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11357018 ↗
• InjuryFeb 22, 2021Naturally Worn; Sharp Edges; Naturally Worn; Sharp Edges

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THREE JOURNEY II BCS BOX PREP GD SIZE 3-5 ARE WORN DOWN LEAVING METAL SHAVINGS IN PATIENT. ALSO SHARP AND JAGGED FROM EXCESSIVE USE. THERE WAS A TECHNIQUE CHANGE FOR COMPLETING THE PROCEDURE. INSTRUMENTS INSIDE THE PATIENT. NO DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11357015 ↗
• InjuryFeb 22, 2021Naturally Worn; Sharp Edges; Naturally Worn; Sharp Edges

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THREE JOURNEY II BCS BOX PREP GD SIZE 3-5 ARE WORN DOWN LEAVING METAL SHAVINGS IN PATIENT. ALSO SHARP AND JAGGED FROM EXCESSIVE USE. THERE WAS A TECHNIQUE CHANGE FOR COMPLETING THE PROCEDURE. INSTRUMENTS INSIDE THE PATIENT. NO DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11357014 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY ITEM BROKE WHILE IT WAS BEING USED. SCREW FELL OUT. SURGERY WAS COMPLETED WITH SAME DEVICE.

  Patient problems: No Information

  MAUDE report 8443980 ↗

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