MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE REVISION FEMORAL SIZE 2 LEFT NONPOROUS; KNEE COMPONENT

Model Number	KFCCNP2L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/24/2020
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, on (b)(6) 2020 the patient underwent revision and change of the femoral component to advance revision with stem in case of ligament instability.In the course of periprosthetic fracture of the distal femur and removal of the connection between the femoral component and stem without trauma.On (b)(6) 2020 the patient had a complete change to another implant.No relevant previous illnesses.Additional information received on 08/18/2020 : sales order was found , adding new incidents with products and lot numbers.(b)(6).

• Brand Name: ADVANCE REVISION FEMORAL SIZE 2 LEFT NONPOROUS
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10514197
• Report Number: 3010536692-2020-00612
• Device Sequence Number: 1178918
• Product Code: JWH
• UDI-Device Identifier: M684KFCCNP2L1
• UDI-Public: M684KFCCNP2L1
• Combination Product (Y/N): N
• PMA/510(K) Number: K990030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: KFCCNP2L
• Device Catalogue Number: KFCCNP2L
• Device Lot Number: 1810288
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR