MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4+ 10MM RIGHT; KNEE COMPONENT

Model Number	EIS4P10R
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 underwent r tkr on (b)(6) 2023.Revised on (b)(6) 2025 due to infection.Insert revised with another of the same size.(b)(4).
Additional Manufacturer Narrative
This female patient was revised approximately 28 months after the index operation due to infection.The revised implant was not returned.Additionally, mpo has not received any clinical information to confirm the presence or source of infection.This lot was manufactured in 2023.Review of the device history record (dhr) for the subject lot indicates that this part met all established acceptance criteria throughout manufacturing processes, including all aspects related to cleaning and sterilization processes.Furthermore, review of historical complaint data confirms no other reported instances for the subject manufacturing lot nor for other manufacturing lots from the same sterile batch.Infection is a known possible adverse effect of any surgical procedure and is captured within mpo risk management and relevant knee systems package insert.Conclusions regarding the source of infection or other possible contributing factors cannot be made for this case.There were no trends identified for this complaint.Mpo will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, patient underwent r tkr on (b)(6) 2023.Revised on (b)(6) 2025 due to infection.Insert revised with another of the same size.(b)(6).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4+ 10MM RIGHT
• 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: 23486955
• Report Number: 3010536692-2025-00361
• Device Sequence Number: 10526846
• Product Code: HRY
• UDI-Device Identifier: M684EIS4P10R1
• UDI-Public: M684EIS4P10R1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: EIS4P10R
• Device Catalogue Number: EIS4P10R
• Device Lot Number: 1957988
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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 Age: 75 YR
• Patient Sex: Female