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

Model Number	NX230
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 postoperative loosening following a right total knee arthroplasty.According to the available operative report, the patient underwent a right total knee arthroplasty on (b)(6) 2022, for right knee tricompartmental osteoarthritis.The procedure utilized aesculap components which were cemented using palacos bone cement.The operative report documented that the procedure was completed without reported intraoperative complications.Trialing and final implantation demonstrated full extension and flexion, no instability, and satisfactory patellar tracking.The patient was taken to recovery in good condition.The operative report did not document intraoperative evidence of loosening, device malfunction, or other device-related complications at the time of the index procedure.A clinic note dated (b)(6) 2022 indicated that the patient's range of motion was back to 95 or 100 but stated that the patient still walked with a limp.This report is filed under ais reference (b)(4).

• Brand Name: VEGA SYSTEM® PS+
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 25621038
• Report Number: 3005673311-2026-00130
• Device Sequence Number: 9094261
• Product Code: OOG
• UDI-Device Identifier: 04046963811242
• UDI-Public: (01)04046963811242(11)201113(17)251112(10)52648362
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2026
• Report Date (Section F): 06/25/2026

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 Expiration Date: 11/12/2025
• Device Model Number: NX230
• Device Catalogue Number: NX230
• Device Lot Number: 52648362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2026
• Device Age: 63 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2026
• 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: 06/25/2026