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

Model Number	NX029Z
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 issues following a left knee prosthesis.According to available records, the patient underwent a left total knee arthroplasty on (b)(6) 2017, for degenerative joint disease.Subsequently, the patient underwent a left total knee arthroplasty on (b)(6) 2021.Both procedures were reported to be completed without intraoperative complications.Postoperatively, the patient initially reported improvement.At follow-up on (b)(6) 2021, the patient was noted to be doing well without pain or complaints.On (b)(6) 2022, the patient reported a fall with subsequent left knee pain, decreased range of motion, and instability.Imaging and clinical findings at that time noted degenerative changes and ligamentous laxity.The patient continued to report persistent knee symptoms despite conservative management, including injections.On (b)(6) 2022, the patient reported ongoing knee pain; imaging at that time did not demonstrate loosening.At follow-up on (b)(6) 2026, imaging demonstrated a left total knee prosthesis in place with findings of mechanical loosening of the femoral component, associated lucency, and instability.Clinical examination noted ligamentous laxity, effusion, and pain.The event is filed under ais reference (b)(4).

• Brand Name: AS 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: 25055702
• Report Number: 25055702
• Device Sequence Number: 9354091
• Product Code: JWH
• UDI-Device Identifier: 04046963810122
• UDI-Public: (01)04046963810122(11)191107(17)291106(10)52557102
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2026
• Report Date (Section F): 07/24/2026

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 Model Number: NX029Z
• Device Catalogue Number: NX029Z
• Device Lot Number: 52557102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2026
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 07/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 204 LB
• Date Report Sent to FDA: 04/30/2026