MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION MP CS INSERT SIZE 5 STANDARD 14MM LEFT; KNEE COMPONENT

Model Number	EIS5S14L
Medical Device Problem Codes	Break (1069); Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, first operation at (b)(6) in 2017.Visited (b)(6) on suspicion of infection.It will be removed for infection on (b)(6) 2020 and (b)(6) 2021.During the operation on (b)(6) 2021, his tibial base was clearly damaged when removed.Physician's findings: since there are no findings of metallosis, it is unlikely that the implant had been damaged first, but i am worried that the implant may be easily damaged.Reporter's findings and response status; it seems that the scaffolding was lost due to the influence of the infection and it was damaged.However, because there are many related facilities, we would like to confirm that the implant meets our safety standards.(b)(4).Additional information received on 02/05/2021 from reliability engineer: adding new products to the group with its corresponding codes.
Additional Manufacturer Narrative
Additional information was received for this event on 02/05/2021: please remove code 2988 based on the investigation and product return.Added name of initial reporter.

• Brand Name: EVOLUTION MP CS INSERT SIZE 5 STANDARD 14MM LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11371804
• Report Number: 3010536692-2021-00109
• Device Sequence Number: 19798156
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S14L1
• UDI-Public: M684EIS5S14L1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: EIS5S14L
• Device Catalogue Number: EIS5S14L
• Device Lot Number: 1693063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention