MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® CANAL FILLING STEM EXTENSION 12MM X 140MM; KNEE COMPONENT

Model Number	KSP11140
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/15/2023
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, physician performed a revision of a tibial implant on (b)(6) 2022.A 12 mm by 140 mm stem was connected to a size 2 tray.They were impacted together with a single blow.The patient did well initially but returned with noting pain in the region of the tibia.He recalled no trauma.X-rays show the stem starting to disengage from the tray.

• Brand Name: ADVANCE® CANAL FILLING STEM EXTENSION 12MM X 140MM
• 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: 16686140
• Report Number: 3010536692-2023-00057
• Device Sequence Number: 17965215
• Product Code: JWH
• UDI-Device Identifier: M684KSP111401
• UDI-Public: M684KSP111401
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K973524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: KSP11140
• Device Catalogue Number: KSP11140
• Device Lot Number: A1458421766309
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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