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	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient was revised due to implant fracture.Revision njr number: (b)(4).Side: l.Primary asa: p3 - incapacitating systemic disease.Mhra reference no: (b)(4).
Additional Manufacturer Narrative
Mpo received additional information for this event on(b)(6)2021 stating that only the poly insert failed.The insert is reported under medwatch number 3010536692-2021-00313.There is no alleged deficiency against the device ktccnp20.Please void the initial report.

• 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: 11803416
• Report Number: 3010536692-2021-00286
• Device Sequence Number: 4381282
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP201
• UDI-Public: M684KTCCNP201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K960617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: Other
• Device Model Number: KTCCNP20
• Device Catalogue Number: KTCCNP20
• Device Lot Number: 1620835
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention