JOURNEY 74012811Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010556882), received between Apr 8, 2019 and Feb 7, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE PLASTIC ON THE HOOKS THAT HOLD THE FEMORAL IMPLANT OF THE JOURNEY LOCK FEM IMPL IMPACT BEGAN TO PEEL OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335828 ↗
• MalfunctionDec 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE TIP OF A JOURNEY LOCK FEM IMPL IMPACT BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056521 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED THAT, ALONG THE TIP OF THE JOURNEY LOCK FEM IMPL IMPAC ARE L-SHAPED BUMPERS THAT WERE BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881476 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT THE JOURNEY LOCK FEM IMPL IMPACT WAS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918425 ↗
• MalfunctionFeb 14, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING EFIP INSPECTION, THE PLASTIC COMING OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326203 ↗
• MalfunctionFeb 14, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING EFIP INSPECTION, THE PLASTIC COMING OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326202 ↗
• MalfunctionFeb 11, 2021Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT DURING EFIP INSPECTION, WAS NOTICED THAT THE PLASTIC OF THE JOURNEY LOCK FEM IMPL IMPACT WAS COMING OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318135 ↗
• MalfunctionFeb 9, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING EFIP INSPECTION, THE PLASTIC COMING OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303153 ↗
• MalfunctionApr 8, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING SURGERY, IMPACTOR WAS DAMAGED. NO PIECES FELL IN THE PATIENT. S&N BACKUP WAS AVAILABLE. NO DELAY TO PROCEDURE. NO INJURY OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491943 ↗

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