MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® CANAL FILLING STEM EXTENSION 15MM X 100MM; KNEE COMPONENT

Model Number	KSP14100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to infection.Srnjr number: (b)(4), side: l, gender: f.

• Brand Name: ADVANCE® CANAL FILLING STEM EXTENSION 15MM X 100MM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 23062513
• Report Number: 3010536692-2025-00326
• Device Sequence Number: 10044586
• Product Code: JWH
• UDI-Device Identifier: M684KSP141001
• UDI-Public: M684KSP141001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K973524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2025
• 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): 09/12/2025

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: KSP14100
• Device Catalogue Number: KSP14100
• Device Lot Number: 125305076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female