MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 6 STANDARD 14MM RIGH; KNEE COMPONENT

Model Number	EIS6S14R
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient underwent r tkr on (b)(6) 2019.Revised on (b)(6) 2021 due to infection.Insert replaced for a size 17, eis6s17r.(b)(6).
Additional Manufacturer Narrative
Additional information received on 02/17/2021: this patient was revised for instability mid flexion, not infection.This event was initially reported incorrectly.Updated description and problem-investigation coding.
Event or Problem Description
Allegedly, the patient underwent r tkr on (b)(6) 2019.Revised on (b)(6) 2021 due to infection.Insert replaced for a size 17, eis6s17r.Australia- c1057.Additional information received from (b)(6) on 02/17/2021: this patient was revised for instability mid flexion and not infection, it was reported incorrectly.

• Brand Name: EVOLUTION MP CS INSERT SIZE 6 STANDARD 14MM RIGH
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11337815
• Report Number: 3010536692-2021-00081
• Device Sequence Number: 3373148
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S14R1
• UDI-Public: M684EIS6S14R1
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: EIS6S14R
• Device Catalogue Number: EIS6S14R
• Device Lot Number: 1549235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR