MAUDE Adverse Event Report: Smith & Nephew, Inc. JOURNEY DCF AP FEM CUT BLK 7; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Catalog Number	74012417
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: JOURNEY DCF AP FEM CUT BLK 7
• Common Device Name: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
• Manufacturer (Section D): Smith & Nephew, Inc.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): Smith & Nephew, Inc.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; +1(512)391-3905
• MDR Report Key: 50304618
• Report Number: 1020279-2026-01160
• Device Sequence Number: 13293235
• Product Code: HRY
• UDI-Device Identifier: 03596010556691
• UDI-Public: 03596010556691
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74012417
• Device Lot Number: 18BM07628
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 02/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown