JOURNEY 74012513Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010556776), received between Sep 1, 2020 and Aug 22, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY FEM TRIAL IMP SZ 3-10 WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032960 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT A JOURNEY FEMORAL TRIAL IMPACTOR SIZE 3-10 IS BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615949 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT THE JOURNEY FEM TRIAL IMP SZ 3-10 BROKE AFTER USE. SINCE THE INCIDENT OCCURRED AFTER PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943724 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT DURING SET UP/INSPECTION A JOURNEY FEM TRIAL IMP SIZE 3-1 HAD A TEAR IN THE RUBBER HANDLE. INCIDENT OCCURRED DURING SET UP/INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11479463 ↗
• MalfunctionMar 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE JOURNEY FEMUR TRIAL IMPACTOR WAS NOTICED THAT THE RUBBER IN THE HANDLE WAS TORN APART. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457284 ↗
• MalfunctionJan 27, 2021Crack; Crack

  IT WAS REPORTED THAT THE JOURNEY FEM TRIAL IMP SZ 3-10 IS CHIPPED AND CRACKED. INCIDENT OCCURRED DURING A STANDARD OFFICE EFIP INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11234614 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY FEMORAL TRIAL IMP SZ 3-10 IS BROKEN. AS NOTICED DURING INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10480620 ↗

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