MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP FEM CS/CR NON-POR SIZE 5 PRIMARY RIGH; KNEE COMPONENT

Model Number	EFSRN5PR
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, black particles were found on the surface of the implant, which cannot be detected with the naked eye.Black powder particles can be clearly seen when the implant comes into contact with bone cement.So, user suspected presence of black particles in the implant and bone cement contaminated by implant.Because of implant is fixed with bone cement, the doctor can but wash it with water and put it in patient's body.Similar cases have happened three times, only this case was recorded by photos.According to the statistics, in this hospital, 150 products (product id:efsrn5pr) has been used in operation.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
It is confirmed that there was no serious injury related to this event, please void the following reports.

• Brand Name: EVOLUTION®MP FEM CS/CR NON-POR SIZE 5 PRIMARY RIGH
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17435900
• Report Number: 3010536692-2023-00143
• Device Sequence Number: 17851229
• Product Code: HRY
• UDI-Device Identifier: M684EFSRN5PR1
• UDI-Public: M684EFSRN5PR1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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: Other
• Device Model Number: EFSRN5PR
• Device Catalogue Number: EFSRN5PR
• Device Lot Number: MP1925372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 07/06/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/14/2023; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown