MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH; KNEE COMPONENT

Model Number	EIS6S10R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
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, patient was revised due to infection.Srnjr number: (b)(6), side: r.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint, efsrn6pr lot 1976108, etpkn6pr lot 169101, and eis6s10r lot 1966373, does not reveal any failure involving this implant.Mpo was made aware of this incident through the united kingdom national joint registry.The revised products were not returned, and no explant images, radiographs, operative notes, or other clinically relevant documentation is available for review to confirm this occurrence or source of the infection.This implant was implanted in the patient for approximately 10 months before revision due to infection was required.This lots were manufactured in 2023.Review of the design history record (dhr) for the subject manufacturing lot indicates that this implant was manufactured to specification, including all aspects related to cleaning and sterility.There is no trend for these implants and failure.No clinical documentation is available to confirm the infection or course of treatment.Infection is a known risk of any surgical procedure.No operative notes or other clinically relevant documentation have been provided to confirm this complaint.The source of the infection cannot be determined from the available information.The microport knee systems package insert (150806) lists "delayed wound healing; deep wound infection (early or late) which may necessitate removal of the prosthesis" as possible adverse effects of total knee arthroplasty.Without additional details regarding these specific cases and the products involved, no additional conclusions can be made.This issue will continue to be monitored through complaint tracking.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH
• 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: 21021508
• Report Number: 3010536692-2024-00505
• Device Sequence Number: 4008747
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10R1
• UDI-Public: M684EIS6S10R1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 12/05/2025

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: EIS6S10R
• Device Catalogue Number: EIS6S10R
• Device Lot Number: 1966373
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male