MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA; KNEE COMPONENT

Model Number	KTCCNP20
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening femur , aseptic loosening tibia , lysis femur and lysis tibia.Revision njr number: (b)(4), side:l, primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10658598
• Report Number: 3010536692-2020-00646
• Device Sequence Number: 3219856
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP201
• UDI-Public: M684KTCCNP201
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K960617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: KTCCNP20
• Device Catalogue Number: KTCCNP20
• Device Lot Number: 0101034787
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention