MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION REVISION POSTERIOR AUGMENT SIZE 6 X 8MM; KNEE COMPONENT

Model Number	EFPAN608
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930)
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 was revised on (b)(6) 2018 due to prosthetic joint infection with nonunion of periprosthetic femur fracture.Femoral and tibial components, patella replaced with non-mpo implants by different surgeon.(right knee).
Additional Manufacturer Narrative
Included adverse event problem codes.

• Brand Name: EVOLUTION REVISION POSTERIOR AUGMENT SIZE 6 X 8MM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11340208
• Report Number: 3010536692-2021-00085
• Device Sequence Number: 11606251
• Product Code: JWH
• UDI-Device Identifier: M684EFPAN6081
• UDI-Public: M684EFPAN6081
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: EFPAN608
• Device Catalogue Number: EFPAN608
• Device Lot Number: 1602604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR