MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 5 STANDARD LEF; KNEE COMPONENT

Model Number	ETPKN5SL
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 left tkr on (b)(6) 2018.Revised on (b)(6) 2021 due to ligament laxity and instability.Replaced with the evolution revision system with stems and augments.Additional history - patella resurfaced on (b)(6) 2019 and insert replaced from 10mm to 14mm, reason unknown.(b)(6).

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 5 STANDARD LEF
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11400114
• Report Number: 3010536692-2021-00123
• Device Sequence Number: 4532267
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN5SL1
• UDI-Public: M684ETPKN5SL1
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: ETPKN5SL
• Device Catalogue Number: ETPKN5SL
• Device Lot Number: 1725970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2021
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1
• Patient Age: 70 YR