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

Model Number	KTCCNP21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to peri prosthetic fracture.Component not revised: advance ii medial pivot tibia insert sz 2 right 12mm product id: kimp212r lot #: 04480875.Advance recessed all poly patella high dome 25mm product id: kprc25hi lot #: 05485149.Revision njr number: 4058499.Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 2+
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10183525
• Report Number: 3010536692-2020-00397
• Device Sequence Number: 10990053
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP211
• UDI-Public: M684KTCCNP211
• 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: 2004
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: KTCCNP21
• Device Catalogue Number: KTCCNP21
• Device Lot Number: 04480120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention