MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 3+ 17MM RIGHT; KNEE COMPONENT

Model Number	EIS3P17R
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient had a non-mpo tkr requiring revision due to infection.A spacer was placed on (b)(6) 2023, with evolution revision knee implanted second stage on (b)(6) 2023.The patient developed a fungal infection, requiring another revision on (b)(6) 2024.Due to debridement that was done due to the infection the surgeon decided that a thicker insert would be more suitable.Revised with a 20mm insert.Products implanted during revision surgery: product: etrkn3sr "evolution® rev tib base nonpor", lot: 1814397, qty: 1.Product: etrkmk36 "evolution® rev tib mod keel", lot: 1984317, qty: 1.Product: esp18100 "evolution® canal fill stem ext", lot: 1807034, qty: 1.Product: efpan404, "evolution® revision posterior" lot: 1754543, qty: 1.Product: esrf0425, "evolution® fem offset adapter", lot: 1755164, qty: 1.Product: esp17100, "evolution® canal fill stem ext", lot: 1788874, qty: 1.Product: efsrn4rr "evolution® femoral stemmed cs" lot: 1926304, qty: 1.Australia - c24-560.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
This 66-year-old female patient was revised approximately 11 months after the previous operation.This patient was reported to have been previously revised for infection as well, during which the mpo revision knee implants were implanted.Mpo did not receive any operative notes or other clinical information to confirm the presence of infection.Review of the device history record (dhr) for this lot indicates that this part met all established acceptance criteria throughout manufacturing processes including all aspects related to cleaning and sterility.Furthermore, there are no other reported complaints of infection for this lot, or for other lots sterilized under the same sterilization batches, sbne14210 and sbne10619.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.Mpo did not identified any trends for these products at the time of this complaint.Mpo will continue to monitor for trends through complaint tracking.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 3+ 17MM 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: 20906899
• Report Number: 3010536692-2024-00497
• Device Sequence Number: 14574499
• Product Code: HRY
• UDI-Device Identifier: M684EIS3P17R1
• UDI-Public: M684EIS3P17R1
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• 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: EIS3P17R
• Device Catalogue Number: EIS3P17R
• Device Lot Number: 10012286601792540
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• 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 Age: 66 YR
• Patient Sex: Female