MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 3 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number EIS3S10L

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Allegedly, patient underwent l tkr on (b)(6) 2023 with pcl retained.Patient had limited range of movement post op - 0-70 deg, knee wouldn't flex.Patient revised on (b)(6) 2023, pcl removed, scar tissue removed, and new insert of the same size used.Post revision range of movement is 0-120 degrees.(b)(4).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 3 STANDARD 10MM LEFT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17256089
• MDR Text Key: 318599184
• Report Number: 3010536692-2023-00134
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS3S10L
• Device Catalogue Number: EIS3S10L
• Device Lot Number: 1947424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female