JOURNEY 74019201Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010557308), received between Jul 18, 2020 and May 5, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT A JOURNEY PATELLA REAMER GUIDE BROKE DURING CLEANING PROCEDURES. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVED WHEN NOTICING THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285886 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT, THE JOURNEY PATELLA REAMER GUIDE SPRING WAS BROKEN. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715390 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERYT, A JOURNEY PATELLA REAMER GUIDE'S SPRING MECHANISM ON HANDLE BROKE, IT IS UNKNOWN IF ANY PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114809 ↗
• InjuryJul 18, 2020Break; Break

  IT WAS REPORTED THAT THE SPRING OF THE JOURNEY PATELLA REAMER GUIDE BROKE DURING SURGERY, OUTSIDE THE PATIENT. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO HARM OR INCONVENIENCE WAS CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10293450 ↗

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