JOURNEY 74019801Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010557339), received between Mar 8, 2021 and Mar 2, 2022 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT THE JOURNEY PAT CEM CLAMP WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13656314 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, THE JOURNEY PAT CEM CLAMP BROKE. IT IS UNKNOWN IF THIS WAS INTERNAL OR EXTERNAL TO PATIENT. THERE WAS A NO SIGNIFICANT DELAY BECAUSE OF THE EVENT AND IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820613 ↗
• MalfunctionApr 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT, FOR A JOURNEY PAT CEM CLAMP IT WAS NOTED DURING PROCESSING THAT THE RED O-RING WAS MISSING FROM THE DEVICE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646910 ↗
• MalfunctionApr 11, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE JOURNEY PATELLA CEMENT CLAMP WAS NOTICED WITH THE RUBBER PAD LOST. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646853 ↗
• MalfunctionMar 8, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT, THE RED GASKET OF A JOURNEY PAT CEM CLAMP BROKE OFF AND IS MISSING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431049 ↗

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