JOURNEY 74012451Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010556752), received between May 13, 2021 and Oct 8, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE LARGE ATTACHMENT PIECE OF ONE (1) JOURNEY SLAP HAMMER EXTRACT BROKE OFF WHILE SURGEON ATTEMPTED TO TAKE THE BOX OSTEOTOME OUT OF THE BCS FEMORAL BOX PREP GUIDE. NO PIECE FELL IN THE PATIENT. THE PROCEDURE WAS PERFORMED, 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 23251585 ↗
• InjuryMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY SLAP HAMMER EXTRACT BROKE WHILE REMOVING THE CUTTING BLOCK FROM THE PATIENT (INSIDE THE PATIENT). IT WAS CONFIRMED THAT PIECES FELL INTO THE PATIENT, AND THEY WERE ALL RETRIEVED USING FORCEPS. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS CONCLUDED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820412 ↗

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