MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM RIGH; KNEE COMPONENT

Model Number EIS4S12R

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, the liner was increased from 12mm to 14mm due to anterior knee pain.The action taken was to resurface the patella.The increased poly size to sz4 14mm was to address slight ligament laxity in flexion over time.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM RIGH
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 9119751
• MDR Text Key: 160080718
• Report Number: 3010536692-2019-01050
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS4S12R1
• UDI-Public: M684EIS4S12R1
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS4S12R
• Device Catalogue Number: EIS4S12R
• Device Lot Number: 1667258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2019
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR