MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE STATURE® FEMUR SIZE 2 LEFT NONPOR; KNEE COMPONENT

Model Number	KFTCNN2L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, during a patient operation today: (b)(6), the doctor and our medical representative identified the mismatch after the patient had already been prepped for surgery.This required our team to urgently replace the item to proceed with the operation, causing delays and significant inconvenience.Product details: 1.Item and batch details outside the box: code: kftcnn2l.Lot#: 17552492028826.2.Actual item inside the box: (b)(6).Additional information received: delay greater than 30 minutes while patient was in surgery.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint is confirmed.Mpo confirmed through correspondence and return of the item that kftcnp4r lot 18344622028778 was found when opening the packaging labeled for kftcnn2l lot 17552492028826.Review of the device history record (dhr) for the subject manufacturing lots indicates that the items were manufactured to specification.The subject lots were rpk-type routings, which are repack rework orders.Lot 17552492028826 was a single piece rpk order and is the complaint part.Lot 18344622028778 was a 2-piece rpk order.These two rpk orders were in close proximity during their routings.Both had all operations where the swap could have occurred completed on the same days by the same operators.Blister data sheets indicate that the orders were packaged at the same time on the same equipment.Therefore, the product swap most likely occurred during these operations.Upon awareness of this issue, mpo initiated distributed product risk assessment (dpra) (b)(4), to escalate the investigation of this issue and to determine resulting actions.Investigation through this risk assessment concluded that a one-to-one swap between the two subject orders had most likely occurred during the rework work orders as a result of operator error.Mpo has initiated field action to address the mislabeled distributed devices.Furthermore, mpo initiated capa action 420 regarding line clearance in environmentally controlled areas.Therefore, investigation of this issue is being managed and addressed through these mitigating actions.Mpo will continue to track this issue through complaint tracking.

• Brand Name: ADVANCE STATURE® FEMUR SIZE 2 LEFT NONPOR
• 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: 21343708
• Report Number: 3010536692-2025-00045
• Device Sequence Number: 15704234
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNN2L1
• UDI-Public: M684KFTCNN2L1
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K063731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/23/2025

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: KFTCNN2L
• Device Catalogue Number: KFTCNN2L
• Device Lot Number: 17552492028826
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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: Unknown