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

Model Number	NX009Z
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 adverse event was reported involving an unknown aesculap ag knee implant system.Specifically, an outside law firm reported that a patient experienced postoperative loosening.Patient underwent a revision surgery.Additional information was not provided.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Investigation on-going.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Eleven (11) photographs were provided.Evaluation of the photographs determined the following: the femoral component (mat.Number unknown) as well as the tibial component (nx051z) shows bone cement adhesive on the intended area.The post of the meniscal component is broken.Furthermore, the meniscal component is still fixed on the tibial component.The device history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Conclusion/preventive measures: based upon the investigation results, a definitive root cause for the implant loosening could not be determined.In the event that the complained device will be provided for investigation in the future, an update of this report will be provided unsolicited.

• 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: 24746034
• Report Number: 3005673311-2026-00066
• Device Sequence Number: 18319826
• Product Code: JWH
• UDI-Device Identifier: 04046963809867
• UDI-Public: (01)04046963809867(11)191129(17)291128(10)52566246
• 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): 04/21/2026
• Report Date (Section F): 03/31/2026

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: NX009Z
• Device Catalogue Number: NX009Z
• Device Lot Number: 52566246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2026
• 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: 03/31/2026
• Supplement Report FDA Received Date: 04/07/2026; 04/21/2026
• 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: Unknown
• Date Report Sent to FDA: 03/31/2026