MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 RIGHT; KNEE COMPONENT

Model Number	KIMP410R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly the patient was revised due to infection.Revision njr number: (b)(4).Side: r.Primary asa: p2- mild disease not incapacitating.The following components have no alleged deficiency and were not revised during this surgery: advance primary femoral size 4 right nonporous kftcnp4r, lot # 1778404 qty.1; advance ii cocr tibia base nonporous sz 4 standard ktccnp40, lot # 1765223 qty.1; advance onlay all poly patella 32mm tripeg kpontp32, lot # 1780373 qty.1.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 RIGHT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8865601
• Report Number: 3010536692-2019-00997
• Device Sequence Number: 13970728
• Product Code: JWH
• UDI-Device Identifier: M684KIMP410R1
• UDI-Public: M684KIMP410R1
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K972770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: KIMP410R
• Device Catalogue Number: KIMP410R
• Device Lot Number: 1687318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 12/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR