MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE STATURE® FEMUR SIZE 4 LEFT NONPOR; KNEE COMPONENT

Model Number	KFTCNN4L
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, incorrect implant configuration used.An advance femur stature implant was used in combination with an advance plus size tibia.Surgeon has been made aware and patient is being monitored.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint, kftcnn4l lot 1928059, ktccnp31 lot 1934245, and kimp317l lot 1848326, does not reveal any failure involving these implants.The primary surgery occurred on (b)(6) 2024 where a size 4 femoral implant was improperly implanted along with a size 3 tibial implant and a size 3 medial pivot insert.These implants were not returned for investigation as they are still implanted in the patient.No radiographic images or other medical documentation was provided to assist with the investigation.These lots were manufactured in 2020 (kimp317l) and 2022 (kftcnn4l, ktccnp31).Review of the design history records (dhr) for the subject manufacturing lots indicate that these implants were all manufactured to specification.There are no trends for failures for any of the implants.No failure involving the implants were revealed during the investigation.According to the mpo knee systems package insert (150806-3) ?the potential for success in knee joint replacement is increased by selection of the proper size, shape, and design of the prosthesis.Knee joint prostheses require careful seating and adequate bone support.Smaller sized implants are intended for patients with small bone and normally slight weight.Such components could be inappropriate for other patients.Surgeons are encouraged to use their best medical judgment when choosing the proper implant size regardless of the endosteal area of the bone.? it also states ?periodic, long-term follow up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.

• Brand Name: ADVANCE STATURE® FEMUR SIZE 4 LEFT NONPOR
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 20454552
• Report Number: 3010536692-2024-00461
• Device Sequence Number: 18282673
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNN4L1
• UDI-Public: M684KFTCNN4L1
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K063731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: KFTCNN4L
• Device Catalogue Number: KFTCNN4L
• Device Lot Number: 1928059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown