MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD RIG; KNEE COMPONENT

Model Number ETPKN7SR

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Event Description

Allegedly, the patient underwent bilateral total knee replacement on (b)(6) 2014 at (b)(6) hospital.On (b)(6) 2014, the patients c-reactive protein (cpr) level was recorded as high as 234mg/l.On (b)(6) 2018, the patients cpr level was recorded as 284mg/l.Surgeon advised that the patient would require 2 surgeries, or life-long antibiotics in order to treat the condition.(b)(6).

• Brand Name: EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD RIG
• 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: 9473152
• MDR Text Key: 182356002
• Report Number: 3010536692-2019-01188
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN7SR1
• UDI-Public: M684ETPKN7SR1
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2019

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: Health Professional
• Device Model Number: ETPKN7SR
• Device Catalogue Number: ETPKN7SR
• Device Lot Number: 1538383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2019
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 12/16/2019
• 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