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

Model Number	NX033Z
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 failure of a knee prosthesis system that required revision surgery.Postoperative loosening of an aesculap knee implant was allegedly reported.The adverse event is filed under aesculap ag reference no.(b)(4).
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(b)(6)or (b)(6), but stated that the patient still walked with a limp.This report is filed under ais reference xc (b)(6); cc (b)(6).

• 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: 24637495
• Report Number: 3005673311-2026-00014
• Device Sequence Number: 15901860
• Product Code: OOG
• 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: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2026
• 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 Model Number: NX033Z
• Device Catalogue Number: NX033Z
• Device Lot Number: 52617087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 71 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/04/2026; 06/25/2026; 09/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 02/25/2026