MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number	EIS5S10L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/13/2024
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, in a hospital in asturias, there is a patient who underwent surgery a year ago and continues to report continuous pain.When evaluating possible causes, one of the doctors indicates that he believes the femoral component is fractured in its proximal part.Additional information received on 05/28/2024: first surgery on (b)(6) 2021 without patella.After some time, she refers anterior pain (suspect patella) and on (b)(6) 2023 she undergoes a second surgery to implant the patella.Doctor states nothing suspicious is observed.She still refers the same kind of pain (anterior), and after a tc the radiologist states in his report (attached) that there´s a morphologic alteration of the femoral component with an existing cavity of irregular width and sharpened around the intercondylar region that's compatible with a breakage in the prosthesis.The surgeon is really concerned as, despite he doesn't believe that the femoral component could break, there´s a formal report of the hospital stating there´s a problem and prosthesis failure.He is suspicious about any kind of bubble or irregularity in the femoral component but still cannot figure out if this issue will be the root-cause of the pain.Patella implanted on (b)(6) 2023: part id: kpontp32, advance® onlay all-poly, lot:1935373, qty: 1.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT
• 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: 19586695
• Report Number: 3010536692-2024-00359
• Device Sequence Number: 7326469
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S10L1
• UDI-Public: M684EIS5S10L1
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/08/2025

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: EIS5S10L
• Device Catalogue Number: EIS5S10L
• Device Lot Number: 1886013
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 04/08/2025
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 80 KG