MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP FEM CS/CR NON-POR SIZE 5 PRIMARY RIGH; KNEE COMPONENT

Model Number EFSRN5PR

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Allegedly, patient is experiencing clicking and pain when she lays on her side.No follow up with her doctor yet.Additional information received on 04/22/2020 from reliability engineering: product id and lot information.Additional information received on 10/26/2020 from reliability engineering: updated product id and lot information.

• Brand Name: EVOLUTIONMP FEM CS/CR NON-POR SIZE 5 PRIMARY 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: 10748493
• MDR Text Key: 213453507
• Report Number: 3010536692-2020-00662
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EFSRN5PR1
• UDI-Public: M684EFSRN5PR1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EFSRN5PR
• Device Catalogue Number: EFSRN5PR
• Device Lot Number: 1451963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Date Manufacturer Received: 10/26/2020
• 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