JOURNEY 74011857Recalls & reported problems

Summary

The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 00885556085233), received between Jan 4, 2019 and May 31, 2026 — classified as 70 injuries, 318 malfunctions.

The most frequently reported specific device problem is “Break” (228 reports).

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 388 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF AFTER BEING STRUCK WITH A MALLET. NO PIECES FELL INTO THE INCISION. 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 25342818 ↗
• MalfunctionMay 21, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT SPLIT IN HALF WHILE IMPACTING THE FEMUR. 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 25240475 ↗
• MalfunctionApr 20, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF AFTER BEING STRUCK WITH MALLET. IT DID NOT FALL INTO PATIENT. PIECE RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924239 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF AFTER BEING STRUCK WITH MALLET. ALL PIECES WERE RETRIEVED BY HAND. 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 24911302 ↗
• MalfunctionApr 15, 2026Break; Fracture

  IT WAS REPORTED THAT A JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF. ALL PIECES WERE RETRIEVED BY HAND. 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 24889353 ↗
• MalfunctionApr 7, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING THE FEMORAL IMPLANT, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF. THE PROCEDURE WAS RESUMED, 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 24802669 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE TIP OF ONE (1) JRNY II CR LKG FEM IMP BUMPER RT SNAPPED IN HALF WHILE IMPACTING THE FEMUR. ALL PIECES WERE RETRIEVED, CONFIRMED BY PUTTING THE TWO PIECES THAT BROKE BACK TOGETHER. 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 24743222 ↗
• MalfunctionMar 6, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II CR LKG FEM IMP BUMPER RT BROKE UPON SECONDARY IMPACTION OF FEMORAL COMPONENT. ALL PIECES WERE REMOVED AND VERIFIED, BUT IS UNKNOWN HOW WERE THEY REMOVED. THE PROCEDURE WAS RESUMED, 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 24531165 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II CR LKG FEM IMP BUMPER RT BROKE DURING IMPLANTATION OF FEMUR. NO PARTS FRACTURED FROM THE ITEM. ALL WERE ACCOUNTED FOR, BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS RESUMED, 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 24484105 ↗
• MalfunctionFeb 19, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHILE CEMENTING THE COMPONENTS, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF WHEN USING IT AS A SECONDARY IMPACTOR. THE PROCEDURE WAS RESUMED, 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 24388085 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING THE FEMORAL COMPONENT DURING CEMENTING ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF. IT WAS AT THE VERY END OF IMPACTING THE FEMUR, SO A BACK-UP WAS NOT NEEDED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310575 ↗
• MalfunctionFeb 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF WHEN IMPACTING. BOTH PIECES WERE RETRIEVED BY HAND. 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 24291466 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF UPON BEING HIT. NO PIECES FELL INTO THE WOUND, AND THEY ALL WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING AN EQUIVALENT S+N BACKUP DEVICE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451052 ↗
• MalfunctionOct 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC JRNY II CR LKG FEM IMP BUMPER RT FRACTURED IN HALF DURING IMPACTING. NO PIECES FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK UP. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263068 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A JRNY II CR LKG FEM IMP BUMPER RT HAD BROKEN IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066892 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY, ONE JRNY II CR LKG FEM IMP BUMPER RT SNAPPED IN HALF WHEN PLACED ON THE IMPACTOR. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710317 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN ONE (1) JRNY II CR LKG FEM IMP BUMPER RT WAS USED ON AN IMPACTOR, IT BROKE OFF AFTER BEING IMPACTED. NO FRAGMENTS WERE BROKEN OFF. 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 22699998 ↗
• MalfunctionJun 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JRNY II CR LKG FEM IMP BUMPER RT BROKE IN HALF WHILE IMPACTING. 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 22303931 ↗
• MalfunctionJun 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT FRACTURED. 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 22200178 ↗
• MalfunctionJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II CR LKG FEM IMP BUMPER RT BROKE DURING IMPACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185839 ↗
• MalfunctionJun 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, TWO JRNY II CR LKG FEM IMP BUMPER RT BROKE WHILE IMPACTING; IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT'S ANATOMY, SURGERY WAS PERFORMED WITHOUT ANY SURGICAL DELAY USING A BACK-UP DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159784 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE AFTER IMPACTING THE FEMUR. 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 21995036 ↗
• MalfunctionMay 2, 2025Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), WHEN THE SURGEON WAS IMPACTING THE FEMUR, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT CRACKED AND BROKE INTO TWO PIECES. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY USING A SMITH+NEPHEW (S+N) BACK-UP DEVICE. NO PATIENT INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952366 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE IN TWO. THE PIECES THAT FELL INTO THE WOUND WERE REMOVED AND ACCOUNTED FOR. 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 21906146 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER RT BROKE. THE PROCEDURE WAS COMPLETED WITHOUT 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 21458323 ↗