MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 6/4 RIGH; KNEE COMPONENT

Model Number EAI6412R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

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

Event 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).

Manufacturer Narrative

Included adverse event problem codes.

• Brand Name: EVOLUTIONMP ADAPTIVE CS INSER IMPLANT SZ 6/4 RIGH
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11340310
• MDR Text Key: 232326939
• Report Number: 3010536692-2021-00088
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EAI6412R1
• UDI-Public: M684EAI6412R1
• Combination Product (y/n): N
• PMA/PMN Number: K113325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: EAI6412R
• Device Catalogue Number: EAI6412R
• Device Lot Number: 1413275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 04/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR