MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION POROUS KEEL PRIMARY; KNEE COMPONENT

Model Number	ETPK1578
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be uploaded once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, while completing a site initiation for a clinical study, dr.(b)(6) mentioned he had seen his first aspectic loosening of our biofoam tibia product in one of this patients.He indicated he would complete a revision total knee arthroplasty; however, it was not clear if the revision surgery has already been done or was going to be scheduled.
Additional Manufacturer Narrative
Additional information received on 09/22/2020: updated patient information, product lot, incident, implant, explant dates and investigation codes.This event is also captured under report 3010536692-2020-00076.
Event or Problem Description
Allegedly, while completing a site initiation for a clinical study, dr.(b)(6) mentioned he had seen his first aspectic loosening of our biofoam tibia product in one of this patients.He indicated he would complete a revision total knee arthroplasty ; however, it was not clear if the revision surgery has already been done or was going to be scheduled.Additional information received on 01/09/2020 from (b)(6): adding tibial base product number (etpl-b7sl).Confirmation of revision received.Additional information received on 09/22/2020 from (b)(6): adding product information, patient name, implant and explant date.Component not revised: evolution®mp fem cs/cr porous size 7 primary left, product number: efsrp7pl, lot number: 1576883.

• Brand Name: EVOLUTION POROUS KEEL PRIMARY
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9647575
• Report Number: 3010536692-2020-00091
• Device Sequence Number: 2667368
• Product Code: HRY
• UDI-Device Identifier: M684ETPK15781
• UDI-Public: M684ETPK15781
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

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: ETPK1578
• Device Catalogue Number: ETPK1578
• Device Lot Number: 1684665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020; 09/22/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 06/08/2020; 09/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention