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 ongoing complications associated with a vega knee implant.A revision surgery has not yet been scheduled.Additional information has been requested but not yet provided.This report is for the left knee.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: 25414762
• Report Number: 3005673311-2026-00103
• Device Sequence Number: 9556856
• Product Code: JWH
• UDI-Device Identifier: 04046963809904
• UDI-Public: (01)04046963809904(11)210129(17)310128(10)52665540
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026
• Report Date (Section F): 06/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NX011Z
• Device Catalogue Number: NX011Z
• Device Lot Number: 52665540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2026
• Device Age: 65 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 06/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 06/05/2026