MAUDE Adverse Event Report: MICROPORT NAVIBOT SKYWALKER TOTAL KNEE SYSTEM; SKYWALKER ROBOT

Model Number	MPS11000
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Swtks robot was used in an off-label manner.The surgeon calculated the placement of the fem in a way that is not part of the surgical technique.
Event or Problem Description
Allegedly, on (b)(6) 2025 of anterior femoral notching seen on post-op xrays.The procedure was done using the skywalker robot with evo medial-pivot knee implants.The robotic surgical plan showed avoidance of anterior femoral notching.

• Brand Name: SKYWALKER TOTAL KNEE SYSTEM
• Common Device Name: SKYWALKER ROBOT
• Manufacturer (Section D): MICROPORT NAVIBOT; 5677 airline rd.; arlington MA 38002
• Manufacturer Contact: rachael wise ; 5677 airline rd.; arlington, TN 38002
• MDR Report Key: 22073960
• Report Number: 3018565653-2025-00001
• Device Sequence Number: 15553046
• Product Code: OLO
• UDI-Device Identifier: 00850030914002
• UDI-Public: (01)00850030914002
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: MPS11000
• Device Catalogue Number: MPS11000
• Device Lot Number: P028
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown