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

Model Number	NX220
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	External Prosthetic Device Pain (4560)
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced issues with a left knee prosthesis.According to the operative report, a patient with a history of bilateral knee degenerative joint disease and prior total knee arthroplasties presented with ongoing musculoskeletal complaints.The patient underwent a left total knee arthroplasty (tka) on (b)(6) 2021 without intraoperative complications.Subsequently, after a motor vehicle accident in (b)(6) 2022, the patient reported neck, back, hip, and left knee pain.Imaging at that time demonstrated a left total knee prosthesis in place with normal alignment and no evidence of loosening or instability.According to the medical records, following the accident, the patient reported persistent left lower extremity pain with radiation in an s1 distribution, numbness, and ongoing discomfort.An orthopedic evaluation dated (b)(6) 2022, documented pain and discomfort involving the left leg in the s1 distribution.Physical examination demonstrated a positive straight leg raise on the left at 45 degrees with decreased sensation over the lateral three toes.At this time, the patient has not been scheduled to undergo a revision procedure.The event 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: 25668988
• Report Number: 3005673311-2026-00126
• Device Sequence Number: 16064151
• Product Code: JWH
• UDI-Device Identifier: 04046963811181
• UDI-Public: (01)04046963811181(11)200723(17)250722(10)52625945
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026
• Report Date (Section F): 06/30/2026

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: 07/22/2025
• Device Model Number: NX220
• Device Catalogue Number: NX220
• Device Lot Number: 52625945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2026
• Device Age: 71 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• 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
• Patient Weight: 82 KG
• Date Report Sent to FDA: 06/30/2026