MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number EIS5S10L

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when the investigation is complete.

Event Description

Allegedly, instability.The doctor removed the poly and replaced it with a 17mm.One was wasted.

Manufacturer Narrative

Updated event problem codes and patient information.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 10MM LEFT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9350839
• MDR Text Key: 167316467
• Report Number: 3010536692-2019-01143
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S10L1
• UDI-Public: M684EIS5S10L1
• 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: 11/20/2019

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: EIS5S10L
• Device Catalogue Number: EIS5S10L
• Device Lot Number: 1533578
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2019
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 02/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention