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

Model Number	KIMP310R
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is related to the one reported on 3010536692-2021-00108.Patient with bilateral knee replacements that underwent a revision operation on both knees.
Event or Problem Description
Allegedly, this patient has bilateral knee replacements and was experiencing instability patellofemoral pain.The patient underwent an operation on both knees.A non-microport patella was implanted, and osteophytes were removed off the other patella.Both polyethylene inserts were replaced.

• 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: 11371941
• Report Number: 3010536692-2021-00110
• Device Sequence Number: 11727205
• Product Code: JWH
• UDI-Device Identifier: M684KIMP310R1
• UDI-Public: M684KIMP310R1
• 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: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: KIMP310R
• Device Catalogue Number: KIMP310R
• Device Lot Number: 016310837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR