JOURNEY 74018911Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 03596010557292), received between Feb 19, 2019 and Aug 6, 2026 — classified as 2 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break

  It was reported that, during a TKA surgery, the JOURNEY ART ISRT ASSM TOOL was broken. 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 50160813 ↗
• MalfunctionJun 25, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF ONE (1) JOURNEY ART ISRT ASSM TOOL BROKE OFF WHILE TRYING TO INSERT THE POLY INTO 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 25626110 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE RESISTANCE SPRING OF ONE (1) JOURNEY ART ISRT ASSM TOOL BROKE OFF ON ONE SIDE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539149 ↗
• MalfunctionJun 12, 2025Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY ART ISRT ASSM TOOL WOULD NOT ENGAGE THE INSERT AS DESIGNED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. DURING INVESTIGATION IT WAS FOUND THAT THE 0.1858" X .290"DOWEL PIN APPEARS TO BE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199051 ↗
• MalfunctionSep 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SPRING OF THE JOURNEY ART ISRT ASSM TOOL BROKE, IT WONT CLAMP TO ENGAGE POLY AND THE HANDLE WONT COMPRESS. NO PIECES FELL INTO PATIENT. 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 20296156 ↗
• MalfunctionDec 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JOURNEY ART ISRT ASSM TOOL BROKE OUT OF PATIENT IN THE PROCESS OF INSERT PLACEMENT. THE PROCEDURE WAS RESUMED, AFTER NO DELAY, BUT IT IS UNKNOWN HOW. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275266 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSERTION, WHILE PERFORMING A TKA, THE SPRING ON A JOURNEY ART ISRT ASSM TOOL BROKE. HOWEVER, ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537938 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, WHILE WASHING A JOURNEY ART ISRT ASSM TOOL THE DEVICE BROKE AND THE PIECE THAT PROVIDES TENSION GOT DETACHED. SINCE THE INCIDENT OCCURRED AFTER THE PROCEDURE, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535463 ↗
• MalfunctionJun 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE JOURNEY ART ISRT ASSM TOOL BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED. UPON INVESTIGATION, IT WAS FOUND THAT THE THE BASEPLATE HOOK (AT THE TIP) IS CHIPPED ON THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861064 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT THE POLY GUN OF A JOURNEY ARTICULAR INSERT ASSEMBLY TOOL WAS FOUND BROKEN ON THE INNER TENSION PIECE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14481168 ↗
• MalfunctionMay 14, 2022Break; Corroded; Detachment of Device or Device Component; Break; Corroded; Detachment of Device or Device Component

  IT WAS REPORTED THAT, ONE OF THE SPRING LOADED TABS OF THE JOURNEY ART ISRT ASSM TOOL DETACHED AND THE RIVET IS RUSTED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403007 ↗
• MalfunctionOct 11, 2021Connection Problem; Mechanics Altered; Connection Problem; Mechanics Altered

  IT WAS REPORTED THAT, A JOURNEY ARTICULAR INSERT ASSEMBLY TOOL WILL NOT GRAB, IT DOESN'T WORK PROPERLY. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED, FOR WHICH PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605507 ↗
• MalfunctionJun 14, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT A R3 OFFSET IMPACTOR HAD A PART MISSING. NO FURTHER DETAILS WERE GIVEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991681 ↗
• MalfunctionJun 4, 2021Mechanical Problem; Connection Problem; Mechanical Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT A JOURNEY FEM IMPACT BUMPER LT ((B)(4)) HAD A PIECE MISSING A LUG ON BOTTOM AND CRACKED. THE GROOVES THAT SLIDE ONTO THE JRNY II TKA FEM TRIAL SZ 3 LT ((B)(4)) WERE STRIPPED AND IT DID NOT LOAD PROPERLY, AND ALSO A JOURNEY ART ISRT ASSM TOOL ((B)(4)) HAD NO TENSION AND DID NOT WORK TO SEAT POLY. DEVICES OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942601 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHILE THE INSTRUMENT WAS OUTSIDE OF THE PATIENT, THE JOURNEY ART ISRT ASSM TOOL WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942467 ↗
• MalfunctionJun 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING STERILIZATION PROCESS, IT WAS FOUND THAT THE INNER METAL CLASP IN THE HANDLE OF THE JOURNEY ART ISRT ASSM TOOL WAS BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934740 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED THAT, THREE (3) JOURNEY ART ISRT ASSM TOOL HAVE BROKEN SPRINGS. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894116 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED THAT, THREE (3) JOURNEY ART ISRT ASSM TOOL HAVE BROKEN SPRINGS. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894098 ↗
• MalfunctionMay 20, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TKA SURGERY, THE JOURNEY ART INSERT ASSM TOOL DID NOT ENGAGE POLY. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860170 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BARS THAT ACTS AS SPRING MECHANISM ON A JOURNEY ART ISRT ASSM TOOL BROKE OUTSIDE THE 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 11860154 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, A JOURNEY ART ISRT ASSM TOOL WAS FOUND BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821616 ↗
• MalfunctionMay 13, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA, THE JRNY II BCS XLPE ART ISRT SZ 1-2 RT 9MM ((B)(4)) COULD NOT BE INSERTED WITH THE JOURNEY ART ISRT ASSM TOOL ((B)(4)). INSTRUMENT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING BOTH S+N BACK-UP DEVICES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821468 ↗
• MalfunctionMay 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TKA, THE JOURNEY ART ISRT ASSM TOOL WAS NOT WORKING PROPERLY, SINCE IT DID NOT SNAP THE INSERT IN PLACE ONTO THE TIBIAL BASEPLATE. NO SURGICAL DELAY WAS REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE OR A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817255 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT, A JOURNEY ART ISRT ASSM TOOL IS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803356 ↗
• MalfunctionMay 10, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA, A JOURNEY ART ISRT ASSM TOOL DID NOT WORK PROPERLY TO HELP SEAT POLY INTO BASEPLATE. INSTRUMENT OUTSIDE 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 11798554 ↗

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