MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 4 RIGHT NONPOROUS; KNEE COMPONENT

Model Number	KFTCNP4R
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening femur; aseptic loosening tibia component not revised: patella, revision njr number: 4481492, side: r, primary asa: p1 - fit and healthy.

• Brand Name: ADVANCE® PRIMARY FEMORAL SIZE 4 RIGHT NONPOROUS
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10179165
• Report Number: 3010536692-2020-00390
• Device Sequence Number: 19473057
• Product Code: JWH
• UDI-Device Identifier: M684KFTCNP4R1
• UDI-Public: M684KFTCNP4R1
• 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: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

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: KFTCNP4R
• Device Catalogue Number: KFTCNP4R
• Device Lot Number: 8346725
• 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: 06/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention