MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 7 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number EIS7S10L

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Osteopenia/ Osteoporosis (2651); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to knee tightness and inability to perform flexion.Soft tissues removed and liner exchanged with the same size liner.Product no revised: advance evolution product id: k0001288 , lot # 1746398, qty 2.Evolution femoral product id: efsrn7pl, lot # 1776909.Evolution tibial product id: etpkn7sl, lot # 1766941.

• Brand Name: EVOLUTION MP CS INSERT SIZE 7 STANDARD 10MM LEFT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9836007
• MDR Text Key: 184423637
• Report Number: 3010536692-2020-00241
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS7S10L1
• UDI-Public: M684EIS7S10L1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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
• Device Operator: Other
• Device Model Number: EIS7S10L
• Device Catalogue Number: EIS7S10L
• Device Lot Number: 1767643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2020
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 10/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention