JOURNEY 74012514Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00885556415115), received between Apr 2, 2019 and Mar 31, 2026 — classified as 3 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE DURING NORMAL USE. 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 24750368 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 WAS BROKEN WHEN HIT BY THE MALLET. 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 24483608 ↗
• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN REMOVING ONE (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 THE END BROKE OFF. 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 24379076 ↗
• MalfunctionJun 5, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 WAS BROKEN. 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 22155768 ↗
• MalfunctionApr 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE WHILE SURGEON WAS IMPACTING. ALL BROKE PIECES WERE RETRIEVED. 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 21828533 ↗
• MalfunctionJan 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW OF ONE (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 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 21240888 ↗
• MalfunctionJan 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE MIDDLE PIECE OF A (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE OFF WHILE IMPACTING. 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 21091995 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE END OF THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 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 19660104 ↗
• MalfunctionJun 26, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 HAD A METAL CENTER PIECE BROKEN. 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 19619359 ↗
• MalfunctionDec 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE. THE METAL PART THAT HAS A SCREW BROKE OFF WHEN IMPACTING THE TRIAL. 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 18267453 ↗
• MalfunctionAug 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 GOT BROKEN IN TWO PIECES. NO PIECES FELL INSIDE THE PATIENT. 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 17503210 ↗
• MalfunctionMar 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II TKA FEM TRL IMPACTOR SZ1-10 CAME APART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. VISUAL INSPECTION REVEALED THE TOP LATERAL MEDIAL METAL PIECE ON THE DEVICE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635181 ↗
• MalfunctionOct 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER SURGERY AND STERILIZATION, IT WAS NOTICED THAT THE ADJUSTABLE METAL PIECE ON THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 HAS BROKEN OFF OF THE MAIN IMPACTOR. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523454 ↗
• MalfunctionSep 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, WHILE IMPACTING THE FEMORAL TRIAL ON THE FEMUR DURING A TKA SURGERY, THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE. SURGEON DESCRIBED THE IMPACTOR BEING LOOSE PRIOR TO BREAKAGE. BOTH PARTS WERE SECURED AND REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED, WITH MINIMAL DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461738 ↗
• MalfunctionSep 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE METAL SLOT OF THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 THAT HOLDS TRIAL IN PLACE BROKE OFF. NO PIECES BROKE INSIDE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460841 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY A JOURNEY II TKA FEMORAL TRIAL IMPACTOR SIZE 1-10 BROKE INTO SEVERAL PIECES AFTER THE SURGEON COMPLETED INSERTING THE IMPLANT. IT IS UNKNOWN IF ANY PIECES OF THE BROKEN DEVICES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13474962 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE INTO PIECES. NO PIECES WHERE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122097 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CAPTURE OF A JOURNEY II TKA FEMORAL TRIAL IMPACTOR SIZE 1-10 BROKE OFF WHILE TIGHTENING TO TRIAL, ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114370 ↗
• InjuryNov 25, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE PUTTING JRNY II TKA FEM TRL IMPACTOR SZ1-10 HEAD ON, SURGEON MALTED THE IMPACTOR AND A PIECE SHEARED OFF. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875252 ↗
• MalfunctionAug 27, 2021Break; Break

  IT WAS REPORTED THAT, A JRNY II TKA FEM TRL IMPACTOR SZ1-10 WAS FOUND BROKEN. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379141 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THAT, THE HANDLE OF A JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE OFF. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243566 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING CLEANING, A JOURNEY II TKA FEM TRIAL IMPACTOR SIZE 1-10 BROKE. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171127 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT THE ATTACHMENT TO HANDLE OF THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743250 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT THE ATTACHMENT TO HANDLE OF THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743248 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT THE ATTACHMENT TO HANDLE OF THE JRNY II TKA FEM TRL IMPACTOR SZ1-10 BROKE OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a