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

Model Number	NX053Z
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
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.
Event or Problem Description
According to the event description: a patient alleges post-operative loosening of aesculap knee implant.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Eight (8) photographs of the left knee were provided for evaluation; photographs of the right knee were not provided.Evolution of the photographs determined the following: the femoral component (nx011z) as well as the tibial component (nx053z) shows nearly no bone cement adhesive on the intended area.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 specification valid at the time of production.There are no similar complaints against the same lot numbers.Conclusion/preventive measures: on the basis of the current information and without the complained medical device being available for investigation, a clear root cause cannot be drawn.In the event that the complained medical device will be provided for investigation in the future, an update of this report will be provided unsolicited.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Additional information: a3 - gender, a4 - weight, b5 - description updated, b6 - test data, b7 - medical history, d4 - udi number udpated, f9 approximate age of device.
Event or Problem Description
An outside law firm reported that a patient experienced persistent pain and functional limitation following left total knee arthroplasty (tka).According to the operative report dated (b)(6) 2021, the patient underwent a left tka for osteoarthritis after failure of conservative treatment.The operative report indicates that the components were implanted using bone cement, with appropriate alignment and stability noted intraoperatively.The procedure was completed without reported intraoperative complications, and the patient was transferred to recovery in stable condition.The patient had previously undergone a right tka on (b)(6) 2019.The operative report similarly documented appropriate component implantation with no intraoperative complications.Follow-up evaluation on (b)(6) 2022, indicated that the implants were in place with normal alignment and no evidence of loosening.Physical examination demonstrated normal range of motion and no instability.Subsequent clinical evaluation on (b)(6) 2025, documented complaints of continued left knee pain and decreased mobility.Imaging reportedly showed the prosthesis in place without clear evidence of loosening; however, due to persistent symptoms, additional diagnostic testing was ordered.On (b)(6) 2025, the patient reported worsening left knee pain following a reported twisting event.The patient described constant pain, with associated symptoms including swelling, stiffness, popping, and difficulty with ambulation.

• 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: 24570633
• Report Number: 3005673311-2026-00021
• Device Sequence Number: 15829405
• Product Code: JWH
• UDI-Device Identifier: 04046963810412
• UDI-Public: (01)04046963810412(11)180910(17)280831(10)52454656
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026
• Report Date (Section F): 03/11/2026

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: NX053Z
• Device Catalogue Number: NX053Z
• Device Lot Number: 52454656
• 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
• Device Age: 90 MO
• 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: 03/11/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/06/2026
• 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: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 03/11/2026