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

Model Number	EIS6S10L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to infection.Srnjr number: (b)(6).Side: l.Gender: m.Non revised products: product id: efsrn5pl evolution® mp fem cs/cr non-porous size 5 primary left/ lot.No.: 1973342/ qty: 1.Product id: etpkn6sl evolution® mp tibial base keeled non-porous size 6 standard left/ lot.No.: 197723/ 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 6 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: 19615999
• Report Number: 3010536692-2024-00376
• Device Sequence Number: 6963020
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10L1
• UDI-Public: M684EIS6S10L1
• 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): 08/14/2024

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: EIS6S10L
• Device Catalogue Number: EIS6S10L
• Device Lot Number: 1972241
• 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: 06/26/2024
• Supplement Report FDA Received Date: 08/15/2024
• 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: 57 YR
• Patient Sex: Male