MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS; KNEE COMPONENT

Model Number	KFTCNP3R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to periprostheticfracture.Component not revised: advance ii cocr tibia base nonporous sz 3 standard product id: ktccnp30 lot id: 1736502.Advance ii medial pivot tibia insert sz 3 right 12mm product id: kimp312r lot id: 1512029.Revision njr number: 4373718.Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10207157
• Report Number: 3010536692-2020-00457
• Device Sequence Number: 10996946
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNP3R1
• UDI-Public: M684KFTCNP3R1
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K972626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: Health Professional
• Device Model Number: KFTCNP3R
• Device Catalogue Number: KFTCNP3R
• Device Lot Number: 1719397
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention