JOURNEY 74012410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010556622), received between Feb 25, 2021 and Feb 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE THE SURGEON WAS SAWING, THE JOURNEY DCF AP FEM CUT BLK 10 BROKE. SURGERY WAS RESUMED AFTER NO DELAY WITH A SN BACK-UP DEVICE. NO FURTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442410 ↗
• MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SCREW OF A JOURNEY DISTAL CUT FIRST ANTERIOR POSTERIOR FEMORAL CUTTING BLOCK SIZE 10 WAS FOUND TO BE LOOSE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636766 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, THE ANTERIOR/POSTERIOR RIGHT CHAMFER SLOT ON THE JOURNEY DCF AP FEMORAL CUTTING BLOCK SZ 10 WAS NOTICED TO BE BROKEN. THERE WAS NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11383231 ↗

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