MAUDE Adverse Event Report: Smith & Nephew, Inc. JOURNEY FEM IMPACT BUMPER LT; Orthopedic Manual Surgical Instrument

Catalog Number	74012821
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, one (1) journey fem impact bumper lt broke upon impaction.The procedure was resumed, without any delay, using a equivalent s+n back-up product.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).

• Brand Name: JOURNEY FEM IMPACT BUMPER LT
• Common Device Name: Orthopedic Manual Surgical Instrument
• 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: 50693642
• Report Number: 1020279-2026-01246
• Device Sequence Number: 18563211
• Product Code: LXH
• UDI-Device Identifier: 03596010556899
• UDI-Public: 03596010556899
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 74012821
• Device Lot Number: 24hm01513
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2024
• 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