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

Model Number	NX051Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
An adverse event was reported involving an unknown aesculap ag knee implant system.Specifically, it was reported that there was postoperative loosening.A revision surgery had been planned.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Additional information was not provided.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 ongoing complications associated with a knee implants.Specifically, it was reported that there was postoperative loosening.Patients alleged chronic, worsening right knee pain in the setting of prior right knee surgeries, including total knee arthroplasty and revision procedures.Physical examination demonstrated swelling and tenderness of the right knee joint with impaired mobility, including difficulty turning while ambulating and use of a cane.The patient underwent a right total knee arthroplasty revision on (b)(6), 2026 and was implanted with another manufacturer's device.The event is filed under ais reference (b)(6)cc (b)(6).

• 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: 24556599
• Report Number: 3005673311-2026-00006
• Device Sequence Number: 13160167
• Product Code: JWH
• 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: 2020
• Device Explanted Year: 2026
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026
• Report Date (Section F): 06/29/2026

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: NX051Z
• Device Catalogue Number: NX051Z
• Device Lot Number: 52538464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 79 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 06/01/2026; 06/29/2026
• 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: Female
• Date Report Sent to FDA: 02/25/2026