MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA; KNEE COMPONENT

Model Number	KTCCNP30
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to instability | malalignment.Revision njr number: (b)(4), side: l, primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15169433
• Report Number: 3010536692-2022-00275
• Device Sequence Number: 12017237
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP301
• UDI-Public: M684KTCCNP301
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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: KTCCNP30
• Device Catalogue Number: KTCCNP30
• Device Lot Number: 1486525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown