JOURNEY 74012831Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 03596010556905), received between Jun 9, 2019 and Jun 12, 2026 — classified as 4 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (28 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY FEM IMPL IMPACTOR WAS BROKEN UPON THE FINAL IMPACTION AND ALL THE PIECES WERE RECOVERED. 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 25484860 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT, DURING A TKR SURGERY, ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE DURING IMPACTION. 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 25145369 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY FEM IMPL IMPACTOR BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722351 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FEM IMPL IMPACTOR BROKE UPON IMPACTION. 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 23437881 ↗
• MalfunctionJul 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE OFF WHEN IMPACTING THE FEMUR ONTO THE PATIENT. ALL BROKEN PIECES WERE RETRIEVED BY TWEEZERS. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT 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 22543520 ↗
• MalfunctionDec 30, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE UPON IMPACTION. 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 21034894 ↗
• MalfunctionNov 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN IMPACTING FEMORAL IMPLANT, THE HEAD OF THE JOURNEY FEM IMPL IMPACTOR BROKE OFF. NOTHING FELL INSIDE THE WOUND. 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 20678463 ↗
• MalfunctionNov 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE OFF DURING INTENDED USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605848 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE HEAD OF ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE OFF. NOTHING FELL INTO THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526917 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE HEAD OF A JOURNEY FEM IMPL IMPACTOR CAME OFF. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026857 ↗
• MalfunctionApr 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING WHEN IMPACTING THE FEMORAL COMPONENT IN A TKA SURGERY, THE HEAD OF ONE (1) JOURNEY FEM IMPL IMPACTOR DETACHED FROM THE HANDLE WHILE IMPACTING. SCREW WAS PRESENT BUT BECAME LOOSE ON IMPACTING LEADING TO ULTIMATE FAILURE. IT WAS REMOVED WITH FORCEPS. SUCTION WAS USED TO ENSURE ANY POSSIBLE BROKEN PIECES WERE REMOVED. 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 19021156 ↗
• MalfunctionFeb 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF A JOURNEY FEM IMPL IMPACTOR BROKE OFF DURING FEMUR IMPACTION, NOTHING FELL INSIDE THE PATIENT. 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 18719237 ↗
• MalfunctionFeb 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE OFF WHILE THE SURGEON WAS IMPACTING THE FEMUR IMPLANT. IT IS UNKNOW IF ANY PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645940 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY, ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE. IT IS UNKNOWN HOW WAS COMPLETED THE PROCEDURE AND IF DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450972 ↗
• MalfunctionMay 23, 2023Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY FEM IMPL IMPACTOR SNAPPED AT THE NECK JUNCTION CLOSE TO THE BUMPER. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989312 ↗
• MalfunctionMay 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY A JOURNEY FEM IMPL IMPACTOR WAS FRACTURED DURING IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895031 ↗
• MalfunctionMar 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE GREY PIECE AND SCREW BROKE OFF ONE (1) JOURNEY FEM IMPL IMPACTOR BROKE ON IMPACTION. 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 16579969 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT THE JOURNEY FEM IMPL IMPACTOR IS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED. UPON INVESTIGATION, IT WAS FOUND THAT THE HEAD OF THE IMPACTOR HAS BROKEN FROM THE REST OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 15535444 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, THE JOURNEY FEM IMPL IMPACTOR SNAPPED AT THE NECK. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514888 ↗
• MalfunctionSep 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A JOURNEY FEM IMPL IMPACTOR BROKE IN HALF. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 15491718 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT THE JOURNEY FEM IMPL IMPACTOR WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279543 ↗
• MalfunctionApr 9, 2022Break; Break

  IT WAS REPORTED THAT, THE JOURNEY FEM IMPL IMPACTOR BROKE IN HALF. 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 14068430 ↗
• MalfunctionApr 1, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT LITTLE PIECES OF PLASTIC OF A JOURNEY FEM IMPL IMPACTOR ARE STARTING TO COME OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO THE SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 13975757 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY FEM IMPL IMPACTOR BROKE AT CASING. DEVICE OUTSIDE THE PATIENT AND NO PIECES FELL INSIDE. 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 13935779 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT THE GREY PLASTIC OF A JOURNEY FEM IMPL IMPACTOR IS CHIPPING OFF. AS THIS WAS NOTICED DURING SET UP FOR A TKA, THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870341 ↗

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