MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE PRIMARY FEMORAL SIZE 5 LEFT POROUS; KNEE COMPONENT

Model Number	KFTCPC5L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/11/2020
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, medial condyle of the femoral component fractured causing pain and instability.Additional information received on 11/20/2020: reason of incident, implant year, incident date, revision date, patient information.Left knee.
Additional Manufacturer Narrative
Updated incident description and product lot number based on product return and additional information received on 02/02/2021.
Event or Problem Description
Allegedly, medial condyle of the femoral component fractured causing pain and instability.Additional information received on 11/20/2020: reason of incident, implant year, incident date, revision date, patient information, and left knee.Additional information received on 02/02/2021: new incidents for the other products since they were revised too.Allegedly, the insert is worn.

• Brand Name: ADVANCE PRIMARY FEMORAL SIZE 5 LEFT POROUS
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10976170
• Report Number: 3010536692-2020-00741
• Device Sequence Number: 19030336
• Product Code: MBH
• UDI-Device Identifier: M684KFTCPC5L1
• UDI-Public: M684KFTCPC5L1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2020
• 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): 05/05/2021

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: KFTCPC5L
• Device Catalogue Number: KFTCPC5L
• Device Lot Number: A110976
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 161