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

Model Number	EIS5S10L
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint is not confirmed.It was indicated that this patient underwent a secondary operation due to infection approximately 19 months after the primary operation.During this revision, the polyethylene tibial insert was revised.This product was not returned to microport.No operative notes or other clinically relevant documentation was provided to confirm the described infection.Review of the device history record (dhr) for this lot indicates that this tibial insert met all established acceptance criteria throughout the manufacturing process.Furthermore, the proper record of sterilization is included within the dhr for this part.Review of historical complaint data reveals no previously reported complaints for this lot and issue.The source of this infection can be determined from the available information.Infection is a known risk of any surgical procedure.The microport knee systems package insert lists "delayed wound healing; deep wound infection (early or late) which may necessitate removal of the prosthesis.On rare occasions, arthrodesis of the involved joint or amputation of the limb may be required" as a possible adverse effect of total knee arthroplasty.There is not a trend for this device and incident mode per mpo trending procedures.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, the tibial insert was revised due to infection, as stated by the surgeon.There were no known issues with the original surgery, or implant alignment.The poly swap was completed without incident.(b)(6) reference no: (b)(4).

• 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
• MDR Report Key: 11703496
• Report Number: 3010536692-2021-00220
• Device Sequence Number: 11517714
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S10L1
• UDI-Public: M684EIS5S10L1
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: Health Professional
• Device Model Number: EIS5S10L
• Device Catalogue Number: EIS5S10L
• Device Lot Number: 1761307
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention