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

Model Number	NX053Z
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 the operative report, the patient underwent a left total knee arthroplasty (tka) on (b)(6) 2020 for degenerative joint disease.The procedure was completed without intraoperative complications.Postoperatively, the patient reported persistent left knee pain despite conservative management, including physical therapy and corticosteroid injections.Clinical notes document continued pain in multiple regions of the knee.Bone scan imaging later demonstrated increased activity at the tip of the left tibial stem with associated pain, noted as possibly representing loosening or physiologic change.At follow-up on (b)(6) 2026, imaging demonstrated a left total knee prosthesis in place with lucency at the femoral component (posterior cut) and the femoral component appearing loose.Clinical findings included pain and suprapatellar clunk, with diagnoses of mechanical loosening and instability of the left knee prosthetic joint.No revision surgery or infection was documented in the available records.This report 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: 24998404
• Report Number: 24998404
• Device Sequence Number: 8765143
• Product Code: JWH
• UDI-Device Identifier: 04046963810412
• UDI-Public: (01)04046963810412(11)200506(17)300505(10)52610499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026
• Report Date (Section F): 08/19/2026

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: NX053Z
• Device Catalogue Number: NX053Z
• Device Lot Number: 52610499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2026
• Device Age: 75 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: 04/27/2026
• Supplement Report FDA Received Date: 08/19/2026
• 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: 205 LB
• Date Report Sent to FDA: 04/27/2026