MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP FEM PS NON POR SIZE 3 PRIMARY RIGHT; KNEE COMPONENT

Model Number EFPSN3PR

Device Problems Unstable (1667); Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, aseptic loosening ,cs and ps type implants were included on both sides and patient had joint instability , the inserts had abnormal wear patterns and some discoloration.(b)(6).

• Brand Name: EVOLUTIONMP FEM PS NON POR SIZE 3 PRIMARY RIGHT
• 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: 9872325
• MDR Text Key: 184677666
• Report Number: 3010536692-2020-00275
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EFPSN3PR1
• UDI-Public: M684EFPSN3PR1
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EFPSN3PR
• Device Catalogue Number: EFPSN3PR
• Device Lot Number: 1623614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2020
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention