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JOURNEY 74011711Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II CR LOCKING FEMORAL IMPLANT IMPACTOR · Class 2

All models of JOURNEY (566)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Smith & Nephew Journey II femoral implant impactor is a surgical instrument used in knee replacement. Many of the 134 reports describe the impactor's plastic parts breaking or the handle seizing and not releasing the implant, and some mention broken pieces entering the wound or joint. There are no deaths and 15 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
134
Deaths reported
0
Injuries reported
15
Recalls naming it
0

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00885556422892), received between May 18, 2017 and May 20, 2025 — classified as 15 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Break” (73 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break73
  • Mechanical Jam23
  • Connection Problem12
  • Fracture11
  • Defective Device5
  • Mechanical Problem4
  • Detachment of Device or Device Component2
  • Difficult to Remove2

Patient problems

  • No Clinical Signs, Symptoms or Conditions71
  • No Known Impact Or Consequence To Patient21
  • No Consequences Or Impact To Patient19
  • No Patient Involvement15
  • No Information8
  • Foreign Body In Patient2
  • Device Embedded In Tissue or Plaque1
  • Failure of Implant1

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 20, 2025Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN IMPLANTING THE (1) JRNY II CR ISRT XLPE RT SZ 5-6 9MM AND THE (1) JRNY II CR FEM OX NP RT SZ 6, THE HANDLE OF ONE (1) JRNY II CR LOCK FEM IMPLANT IMPACTOR SEIZED UP, NOT BEING ABLE TO RELEASE THE IMPLANT FROM THE DEVICE. A BCS FEMUR WAS IMPLANTED INSTEAD AS SECOND CR SIZE 6 FEMUR WAS NOT AVAILABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22054359 ↗
  • MalfunctionDec 2, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING TKA SURGERY, THE PLASTIC RING OF ONE (1) JRNY II CR LOCK FEM IMPLANT IMPACTOR HAD A BREAK AND A PIECE ENTERED WOUND. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. SURGERY WAS NOT DELAYED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20824393 ↗
  • MalfunctionSep 8, 2024Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

    IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II CR LOCK FEM IMPLANT IMPACTOR SEEMED TO MALFUNCTION BECAUSE IT WOULD NO RELEASE THE JRNY II CR FEM OX NP RT SZ 6. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20165896 ↗
  • MalfunctionJun 20, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING RIGHT TKA SURGERY, THE DOCTOR FOUND THAT THERE WAS THE BROKEN PLASTIC PART OF THE JRNY II CR LOCK FEM IMPLANT IMPACTOR IN THE PATIENT'S JOINT AFTER INSERTING THE IMPLANTS AND REMOVED THE PIECE. THE FOUND PLASTIC PART WAS REMOVED FROM THE BODY, BUT IT WAS UNKNOWN IF THERE WERE ANY OTHER BROKEN PARTS. 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 19576862 ↗
  • MalfunctionJan 8, 2024Break; Break

    IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II CR LOCK FEM IMPLANT IMPACTOR BROKE DURING A CASE. IT IS UNKNOWN IF THE BREAKAGE OCCURRED ON THE IMPACTOR ITSELF, OR ON THE BUMPER. IT IS UNCLEAR HOW THIS SURGERY WAS COMPLETED. NO DELAY OR INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18465850 ↗
  • MalfunctionDec 31, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING A TKA, THE JRNY II CR LOCK FEM IMPLANT IMPACTOR PLASTIC PIECE BROKE OFF WHEN LOADING THE IMPLANT ON. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18423033 ↗
  • MalfunctionOct 3, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT THE PLASTIC PIECE ON ONE (1) JRNY II CR LOCK FEM IMPLANT IMPACTOR IS FRACTURED. 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 17860904 ↗
  • MalfunctionJun 13, 2023Fracture; Fracture

    IT WAS REPORTED, THAT DURING TKA SURGERY. THE PLASTIC BUMPER OF A JRNY II CR LOCK FEM IMPLANT IMPACTOR FRACTURED. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17121942 ↗
  • MalfunctionMay 31, 2023Break; Flaked; Fracture; Break; Flaked; Fracture

    IT WAS REPORTED THAT, DURING A TKA, GREY PLASTIC PARTICLES FROM ONE (1) JRNY II CR LOCK FEM IMPLANT IMPACTOR WERE FOUND AFTER FEMORAL IMPACTING. THESE WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17035186 ↗
  • MalfunctionFeb 3, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING A TKA SURGERY, THE RUN (PIECE OF THE IMPACTOR NEXT TO THE KNOB USED FOR THE IMPACTOR TO DISENGAGE FROM THE FEMORAL COMPONENT) OF THE JRNY II CR LOCK FEM IMPLANT IMPACTOR DEVICE BROKE OFF. IT IS UNKNOWN IF PIECES FELL INTO 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 16297512 ↗
  • MalfunctionSep 13, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING SET UP AND INSPECTION FOR A TKA SURGERY, IT WAS FOUND THAT THE LOWER PLASTIC HEAD OF A JRNY II CR LOCK FEM IMPLANT IMPACTOR WAS BROKEN OFF. AS THIS WAS NOTICED BEFORE THE PROCEDURE, THE PATIENT WAS NOT YET INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15411672 ↗
  • MalfunctionAug 24, 2022Fracture; Fracture

    IT WAS REPORTED THAT, A JRNY II CR LOCK FEM IMPLANT IMPACTOR WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15282630 ↗
  • MalfunctionJun 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT, DURING STERILE PROCESSES, IT WAS FOUND THE PLASTIC RINGS OF THE JRNY II CR LOCK FEM IMPLANT IMPACTOR DETACHED WHILE TRYING TO REMOVE CEMENT DURING CLEANING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14819231 ↗
  • MalfunctionMay 21, 2022Break; Break

    IT WAS REPORTED THAT A JRNY II CR LOCK FEM IMPLANT IMPACTOR WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14466823 ↗
  • MalfunctionMay 20, 2022Break; Break

    IT WAS REPORTED THAT A JOURNEY II CR LOCKING FEMORAL IMPLANT IMPACTOR WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14462254 ↗
  • InjuryApr 25, 2022Break; Break

    IT WAS REPORTED THAT, WHILE IMPACTING DURING A TKA SURGERY, THE PLASTIC RING INDICATING LOCK/UNLOCK DIRECTION BROKE OFF OF THE JRNY II CR LOCK FEM IMPLANT IMPACTOR. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14192095 ↗
  • MalfunctionMar 4, 2022Crack; Crack

    IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC PLATE AT TOP OF THE SCREW MODULE IN A JRNY II CR LOCK FEM IMPLANT IMPACTOR WAS CRACKED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13667828 ↗
  • MalfunctionFeb 28, 2022Break; Break

    IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, THE SPRING BROKE IN LOCKING MECHANISM OF THE JRNY II CR LOCK FEM IMPLANT IMPACTOR. 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 13625993 ↗
  • MalfunctionFeb 15, 2022Break; Break

    IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS NOTICED THAT THE CLIPS ON THE PLASTIC COLLARS OF THE JRNY II CR LOCK FEM IMPLANT IMPACTOR ARE BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13532869 ↗
  • MalfunctionJan 12, 2022Break; Break

    IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY II CR LOCK FEM IMPLANT IMPACTOR BROKE. INCIDENT OCCURRED WITH INSTRUMENT OUTSIDE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13239706 ↗
  • MalfunctionNov 10, 2021Break; Break

    IT WAS REPORTED THAT, DURING A (B)(6) SURGERY, A JRNY II CR LOCK FEM IMPLANT IMPACTOR WAS BROKEN. IT IS UNKNOWN IN WHICH MOMENT OF THE SURGERY THE INCIDENT OCCURRED. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND IF IT CAUSED A DELAY. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12787922 ↗
  • MalfunctionOct 21, 2021Break; Break

    IT WAS REPORTED THAT THE PLASTIC LOCKING RING OF A JOURNEY II CR LOCKING FEMORAL IMPLANT IMPACTOR IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12677305 ↗
  • InjurySep 22, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE JRNY II CR LOCK FEM IMPLANT IMPACTOR WAS COLD WELDED SHUT, SO IT COULD NOT GET THE IMPLANT IMPACTOR TO GRAB HOLD OF THE JOURNEY FEMORAL COMPONENT. SURGERY WAS RESUMED, WITHOUT A DELAY GREATER THAN 30MINS, WITH A CHANGE IN SURGICAL TECHNIQUE. NO HEALTH CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12513167 ↗
  • MalfunctionAug 16, 2021Break; Break

    IT WAS REPORTED THAT A JOURNEY II CR LOCKING FEMORAL IMPLANT IMPACTOR KNOB WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12325165 ↗
  • MalfunctionJul 28, 2021Break; Break

    IT WAS REPORTED THAT DURING A TKA A JRNY II CR LOCK FEM IMPLANT IMPACTOR BROKE. SURGERY WAS FINISHED WITH A BACK UP DEVICE, NO DELAY REPORTED. PATIENT STATUS IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12236034 ↗

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Sources and updates

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