MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 10MM RIGH; KNEE COMPONENT

Model Number	EIS7S10R
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2025
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, when implant package was opened, it was noticed even if the implant is marked as r (right side) but actually it is l (left side).
Additional Manufacturer Narrative
The alleged complaint is confirmed.Visual review of a provided image confirms that a left tibial insert is marked as a right tibial insert, eis7s10r lot 2022829.The reporting person confirmed that the left tibial insert was a size 7.During investigation of orders that were processed at the same time, mpo identified a suspect order for a size 7 left tibial insert, eis7s10l lot 2022838.These orders were machined a day apart but were at the laser operation on the same day.Though different operators lasered the orders, the orders were likely at the work station together based on available evidence.At final inspection, three parts from the suspect work order, eis7s10l lot 2022838, were rejected.Specifically, one of the items was scrapped due to having out-of-specification wear thickness.Based on this information, mpo believes that a one-to-one swap occurred between eis7s10r lot 2022829 and eis7s10l lot 2022838.The swapped part in this complaint is the left part, and it is believed that the corresponding right part was scrapped due to having out-of specification wear thickness measurements at final inspection.Therefore, the two subject items have been accounted for, and a distributed product risk assessment is not required.Mpo previously initiated a capa regarding the potential for product swaps.More specifically, actions documented through capa is related to operations associated with line clearance for laser marking work stations.Therefore, no further escalation is deemed necessary as this order was processed prior to implementation of the capa actions.Mpo will continue to monitor for this complaint issue.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 7 STANDARD 10MM 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: 21324536
• Report Number: 3010536692-2025-00041
• Device Sequence Number: 21006755
• Product Code: HRY
• UDI-Device Identifier: M684EIS7S10R1
• UDI-Public: M684EIS7S10R1
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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: EIS7S10R
• Device Catalogue Number: EIS7S10R
• Device Lot Number: 2022829
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male