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

Model Number	KIMP412R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to right poly loosening, possible infection , poly swap and it does not locked in.Previous revision was captured under the incident number : 17100035.

• 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: 10339890
• Report Number: 3010536692-2020-00525
• Device Sequence Number: 11529286
• Product Code: JWH
• UDI-Device Identifier: M684KIMP412R1
• UDI-Public: M684KIMP412R1
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: KIMP412R
• Device Catalogue Number: KIMP412R
• Device Lot Number: 046331064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention