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

Model Number EIS5S14L

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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.

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
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11371804
• MDR Text Key: 240423257
• Report Number: 3010536692-2021-00109
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S14L1
• UDI-Public: M684EIS5S14L1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 04/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention