MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 1; KNEE COMPONENT

Model Number	KIMP414L
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening tibia, instability , malalignment and pain.Revision njr number: 4394823.Side: l.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 1
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10192195
• Report Number: 3010536692-2020-00413
• Device Sequence Number: 835876
• Product Code: JWH
• UDI-Device Identifier: M684KIMP414L1
• UDI-Public: M684KIMP414L1
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: KIMP414L
• Device Catalogue Number: KIMP414L
• Device Lot Number: 1399648
• 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: 06/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention