MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP FEM CS/CR POROUS; KNEE COMPONENT

Model Number EFSRP5PL

Device Problem Improper or Incorrect Procedure or Method (2017)

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: EVOLUTIONMP FEM CS/CR POROUS
• 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: 10420831
• MDR Text Key: 203345861
• Report Number: 3010536692-2020-00577
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: M684EFSRP5PL1
• UDI-Public: M684EFSRP5PL1
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EFSRP5PL
• Device Catalogue Number: EFSRP5PL
• Device Lot Number: 1759666
• 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
• Date Manufacturer Received: 07/27/2020
• 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