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

Model Number ETPK1578

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

This event will be uploaded once the investigation is complete.Trends will be evaluated.

Event 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.

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 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
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9647575
• MDR Text Key: 176987434
• Report Number: 3010536692-2020-00091
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPK15781
• UDI-Public: M684ETPK15781
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention