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

Model Number	NX011Z
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 complications associated with a left total knee replacement (tkr).According to clinical documentation, the patient initially underwent a left total knee replacement on (b)(6) 2022.Following the total knee replacement, the patient experienced persistent symptoms, including pain, instability, recurrent buckling, and limited function of the left knee.An office visit dated (b)(6) 2023 documented 3+ effusion and lateral laxity, with concern for instability.Due to ongoing symptoms, the patient underwent revision left knee arthroplasty on (b)(6) 2023.Operative findings included loosening of the tibial component with observed micromotion.The procedure involved removal of the loosened component and implantation of a revised tibial component with polyethylene insert.No intraoperative complications were reported.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: 24954874
• Report Number: 3005673311-2026-00060
• Device Sequence Number: 20153162
• Product Code: JWH
• UDI-Device Identifier: 04046963809904
• UDI-Public: (01)04046963809904(11)220113(17)320112(10)52736436
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2026
• Report Date (Section F): 04/22/2026

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: NX011Z
• Device Catalogue Number: NX011Z
• Device Lot Number: 52736436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2026
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/16/2026; 07/22/2026
• 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: 04/22/2026