MAUDE Adverse Event Report: AESCULAP AG AS VEGA System® PS; KNEE ENDOPROSTHETICS

Model Number	NX057Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced loosening of the left knee prosthesis.According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2022, for left knee osteoarthritis.The procedure utilized an aesculap vega system.The operative report documented that the procedure was completed without reported intraoperative complications.Intraoperative trialing demonstrated full extension and flexion with appropriate patellar tracking.The implants were placed using third-generation cement technique, and the patient was taken to the post-anesthesia care unit in stable condition.On (b)(6) 2026, the patient was evaluated for left knee pain.The assessment included mechanical loosening of the internal left knee prosthetic joint.A triple-phase bone scan was reported as normal with no prosthetic loosening, fracture, or osteomyelitis; however, the treating physician documented disagreement with the radiology interpretation, noting increased uptake along the patellar component and underneath the femoral component.The patient was reportedly tender in this area, and the physician documented that the findings were consistent with loosening of the hardware.On (b)(6) 2026, the patient underwent revision total knee arthroplasty of the femoral and tibial components for a loose/failed total knee arthroplasty.Intraoperatively, the surgeon documented debonding of the femoral component, particularly anteriorly and posteriorly.The tibial component was also described as completely debonded from the cement and was removed easily with minimal bone loss.The femoral and tibial components were revised and replacement components were implanted.The patient was awakened from surgery and taken to the post-anesthesia care unit in stable condition.This report is filed under ais reference (b)(4).

• Brand Name: AS VEGA System® PS
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 50258558
• Report Number: 50258558
• Device Sequence Number: 21500856
• Product Code: JWH
• UDI-Device Identifier: 04046963810498
• UDI-Public: (01)04046963810498(11)210222(17)310221(10)52670584
• 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: 2022
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026
• Report Date (Section F): 08/14/2026

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: NX057Z
• Device Catalogue Number: NX057Z
• Device Lot Number: 52670584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2026
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• 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: Male
• Date Report Sent to FDA: 08/14/2026