MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 3 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number	EIS3S12L
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to instability.Srnjr number: (b)(6).Side: l.Gender: f.Products no revise: product id: efsrn3pl, evolution® mp fem cs/cr non-porous size 3 primary left, lot: 1940224, qty: 1 product id: kpontp32, advance® onlay all-poly patella 32mm tri-peg, lot: 1936559, qty: 1 product id: etpkn3sl, evolution® mp tibial base keeled non-porous size 3 standard left, lot: 1791625, qty: 1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 3 STANDARD 12MM 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: 21209939
• Report Number: 3010536692-2025-00011
• Device Sequence Number: 8157186
• Product Code: HRY
• UDI-Device Identifier: M684EIS3S12L1
• UDI-Public: M684EIS3S12L1
• 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: 2024
• 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): 10/30/2025

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: EIS3S12L
• Device Catalogue Number: EIS3S12L
• Device Lot Number: 1799767
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female