MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE FEMORAL AUGMENT SIZE 4 X 10MM DISTAL; KNEE COMPONENT

Model Number	KFDAN410
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient suffered pain and instability; loosening of femur and stem.(left knee) component not revised: advance® ii modular titanium tibial base sz 4 std / product id: kttinp40 / lot number: 085268636.

• Brand Name: ADVANCE FEMORAL AUGMENT SIZE 4 X 10MM DISTAL
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11210508
• Report Number: 3010536692-2021-00034
• Device Sequence Number: 17025788
• Product Code: JWH
• UDI-Device Identifier: M684KFDAN4101
• UDI-Public: M684KFDAN4101
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K990030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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: KFDAN410
• Device Catalogue Number: KFDAN410
• Device Lot Number: 025187631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR