MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 5 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number EIS5S10L

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to femoral component oversized and the patient motion was quite limited, with a range of 0 to 30 degrees , with a hard stop at 30 degrees.

• Brand Name: EVOLUTION MP CS INSERT SIZE 5 STANDARD 10MM LEFT
• 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: 10420874
• MDR Text Key: 203342059
• Report Number: 3010536692-2020-00578
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S10L1
• UDI-Public: M684EIS5S10L1
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

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: EIS5S10L
• Device Catalogue Number: EIS5S10L
• Device Lot Number: 1761307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention