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JOURNEY 74031224Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 4 · Class 2

All models of JOURNEY (566)

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

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010671905), received between Nov 12, 2019 and Jan 18, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

Most reported problems

Device problems

  • Break4
  • Crack1
  • Fracture1
  • Mechanical Jam1
  • Naturally Worn1
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 18, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE SURGEON ATTEMPTED TO IMPACT THE JRNY II TKA FEM TRIAL LT SZ 4, A PIECE CHIPPED OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16195148 ↗
  • MalfunctionApr 9, 2022Crack; Mechanical Jam; Naturally Worn; Scratched Material; Crack; Mechanical Jam; Naturally Worn; Scratched Material

    IT WAS REPORTED THAT, THE JRNY II TKA FEM TRIAL LT SZ 4 WOULD GET CAUGHT UP IN THE LATERAL SIDE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED. THE INVESTIGATION FOUND THE DEVICE HAS CRACKS IN THE METAL, SEVERAL GOUGES AND IS WORN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14068442 ↗
  • MalfunctionAug 19, 2020Break; Break

    IT WAS REPORTED THAT THE JOURNEY II TKA FEM TRIAL LEFT SIZE 4 IS BROKEN AND NEEDS TO BE REPLACED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

    Patient problems: No Information

    MAUDE report 10427089 ↗
  • MalfunctionJun 15, 2020Break; Break

    IT WAS REPORTED THAT UPON INSPECTING THE INSTRUMENTS IT WAS NOTICED THAT THE LATERAL SIDE CAPTURE WAS BROKEN AND CRACKED. NO CASE INVOLVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10156246 ↗
  • MalfunctionDec 17, 2019Break; Break

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY, THE FEMUR TRIAL SPLIT IN TWO DURING INSERTION. A BACKUP DEVICE WAS AVAILABLE BUT THE SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9480086 ↗
  • MalfunctionNov 12, 2019Break; Break

    IT WAS REPORTED THAT DURING THE PROCEDURE A SMALL SLIVER OF METAL WAS SEEN FALLING OFF THE TRIAL UPON IMPACTION OF THE TRIAL. NO INJURIES OR DELAYS REPORTED. BACKUP DEVICE AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9309559 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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