JOURNEY 74012812Recalls & reported problems

Summary

The FDA's MAUDE database contains 502 adverse event reports that list this exact device (DI 00885556003541), received between Aug 2, 2017 and Jun 17, 2026 — classified as 38 injuries, 464 malfunctions.

The most frequently reported specific device problem is “Break” (310 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 502 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Fracture; Scratched Material

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC END OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT WAS NOTED BROKEN DURING IMPLANT IMPACTION. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537434 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE. 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 25369686 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, PLASTIC TIP OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE OFF. 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 25342923 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, PLASTIC TIP OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE OFF. 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 25342853 ↗
• MalfunctionMay 8, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE JRN II BCS LCK FEM IMPLANT IMPACT BROKE UPON IMPACTION. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131123 ↗
• MalfunctionApr 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, A PIECE OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT CHIPPED OFF WHILE USING IT. ALL PIECES WERE RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED, OR IF THERE WAS ANY DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919866 ↗
• MalfunctionApr 13, 2026Break; Material Fragmentation

  IT WAS REPORTED THAT, DURING TKA, THE PLASTIC PIECE OF A JRN II BCS LCK FEM IMPLANT IMPACT BROKE OFF. NO PIECES FELL INTO THE WOUND. 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 24867263 ↗
• MalfunctionApr 5, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA, THE GREY PLASTIC TIP OF A JRN II BCS LCK FEM IMPLANT IMPACT BROKE. AT THIS TIME IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787011 ↗
• MalfunctionMar 16, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC END OF TWO (2) JRN II BCS LCK FEM IMPLANT IMPACT WAS NOTED BROKEN DURING IMPLANT IMPACTION. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611127 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT FRACTURED WHILE IMPLANTING. NO BROKEN PIECES WERE LEFT INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717230 ↗
• MalfunctionNov 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565819 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE TIP OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE DURING IMPLEMENTATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533129 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRN II BCS LCK FEM IMPLANT IMPACT BROKE WHILE IMPACTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 23532824 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE PLASTIC TIP OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE IN TWO. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451112 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978304 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE RUBBER TIP ON ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT WAS FRACTURED. THE IMPACTOR WAS NOT ABLE TO PROPERLY SECURE ITSELF TO THE IMPLANT UPON FINAL IMPLANTATION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666216 ↗
• MalfunctionJul 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PLASTIC ON ARTICULATING ARM OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE DURING IMPACTION. ALL THE BROKEN PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552231 ↗
• MalfunctionJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, THE TIP OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293111 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRN II BCS LCK FEM IMPLANT IMPACT IS COMING APART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628148 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT WAS COMING APART/BREAKING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628099 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE INSERTING THE FEMUR TRIAL, THE PLASTIC PIECE OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE OFF. ALL PIECES WERE RETRIEVED BY HAND, WITHOUT CAUSING INJURY TO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531807 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE PLASTIC PIECE OF A (1) JRN II BCS LCK FEM IMPLANT IMPACT THAT HOLDS THE FEMUR, BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458223 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE USING THE JRN II BCS LCK FEM IMPLANT IMPACT, THE PLASTIC PIECE THAT HOLD THE FEMUR HAS BROKEN OFF. ALL EXTERNAL TO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318622 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC PIECE ON THE END OF ONE (1) JRN II BCS LCK FEM IMPLANT IMPACT BROKE OFF. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21098514 ↗
• MalfunctionJan 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JRN II BCS LCK FEM IMPLANT IMPACT BROKE. IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. THERE WAS NO 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 21056805 ↗

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