MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number	EIS4S12L
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, patient was revised on (b)(6) 2019 due to instability.Sz 4 12mm replaced with sz 4 17mm insert.Surgeon error resulting in instability.Australia c842.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9747012
• Report Number: 3010536692-2019-01121
• Device Sequence Number: 13607678
• Product Code: HRY
• UDI-Device Identifier: M684EIS4S12L1
• UDI-Public: M684EIS4S12L1
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: EIS4S12L
• Device Catalogue Number: EIS4S12L
• Device Lot Number: 1743416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR