MAUDE Adverse Event Report: AESCULAP AG VEGA SYSTEM® PS+; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NX210
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced ongoing right knee pain and instability following a right total knee arthroplasty.The patient had a history of end-stage degenerative arthritis of the right knee and underwent a right total knee arthroplasty on (b)(6) 2020.Following surgery, the patient continued to report pain, swelling, and instability.A clinic visit on (b)(6) 2021, documented continued knee swelling and lateral patellar tracking.Subsequent evaluation noted a well-healed incision, range of motion from 0 to 110 degrees, and mid-flexion instability with varus/valgus laxity.Radiographs reportedly demonstrated a well-aligned prosthesis without evidence of loosening, fracture, or mechanical failure.Due to persistent pain and instability, the patient underwent revision right total knee arthroplasty involving polyethylene exchange on (b)(6) 2021.Intraoperative findings included significant medial-lateral instability, crepitation, synovial swelling, and clear joint fluid without evidence of infection.The existing polyethylene insert was removed and replaced with a size 14 aesculap posterior-stabilized polyethylene insert.Synovectomy, debridement, and removal of bony overgrowth were also performed.Knee stability improved following implantation.No intraoperative complications were reported.On (b)(6) 2026, the patient presented with worsening right knee pain.At a follow-up visit on (b)(6) 2026, the patient reported right knee pain, instability, difficulty walking, and limited range of motion.Review of radiographs reportedly showed normal alignment with lucency present and the tibial and femoral components appearing loose.Revision total knee arthroplasty was planned.This report is filed under ais reference (b)(4).

• Brand Name: VEGA SYSTEM® PS+
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 25448581
• Report Number: 3005673311-2026-00115
• Device Sequence Number: 17583455
• Product Code: JWH
• UDI-Device Identifier: 04046963811129
• UDI-Public: (01)04046963811129(11)200319(17)250318(10)52603025
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026
• Report Date (Section F): 06/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2025
• Device Model Number: NX210
• Device Catalogue Number: NX210
• Device Lot Number: 52603025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2026
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 06/09/2026