MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT; KNEE COMPONENT

Model Number	KIMP312R
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly, right "patella oa" is reason for revision, pain & instability.Poly x 12mm was pulled and replaced with a 3x17mm, stryker patella was implanted.Components not revised: advance femur size 3 right kftcpc3r lot 038577450, advance tib base size 3 ktssfm31 lot 127503866, advance modular keel spkt0023 lot 018484504, cancellous bone screw 75520040 x2 lot 028547359, cancellous bone screw 75520025 x2 lot 028551177 & 02851176.
Event or Problem Description
Allegedly, right "patella oa" is reason for revision, pain & instability.Poly x 12mm was pulled and replaced with a 3x17mm, stryker patella was implanted.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8716449
• Report Number: 3010536692-2019-00829
• Device Sequence Number: 1685590
• Product Code: JWH
• UDI-Device Identifier: M684KIMP312R1
• UDI-Public: M684KIMP312R1
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K972770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 02/11/2020

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: KIMP312R
• Device Catalogue Number: KIMP312R
• Device Lot Number: 057434237
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR