MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION POROUS KEEL PRIMARY; KNEE COMPONENT

Model Number	ETPK1556
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem 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 POROUS KEEL PRIMARY
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10421052
• Report Number: 3010536692-2020-00581
• Device Sequence Number: 11503408
• Product Code: MBH
• UDI-Device Identifier: M684ETPK15561
• UDI-Public: M684ETPK15561
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: ETPK1556
• Device Catalogue Number: ETPK1556
• Device Lot Number: 1767971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention