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

Model Number	NN264Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/31/2025
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
The patient underwent revision total knee arthroplasty of the left knee for loosening and failure of prior components.The femoral component was explanted manually; the tibial component was removed with subluxation and periosteal elevator.Severe debonding was noted at both femoral and tibial interfaces, consistent with aseptic loosening.The tibia and femur were sequentially prepared with broaches, reamers, and cutting guides.Trial implants were placed and demonstrated stable fixation with excellent range of motion and varus/valgus stability.Final tibial and femoral implants were implanted using third-generation cementing technique (vacuum mixed, pulse lavage preparation, digital pressurization).A polyethylene insert was placed, confirmed to be well-seated, and secured with a locking screw.The patient tolerated the procedure, was awakened from anesthesia, and transferred to pacu in stable condition.
Additional Manufacturer Narrative
The adverse event is filed under ais reference (b)(4).Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.Xc (b)(4) cc (b)(4).Additional information: b7 patient medical history.E1 initial reporter updated.
Additional Manufacturer Narrative
The adverse event is filed under ais reference no.(b)(4).Investigation results: the complained medical device was not made available for investigation.The investigation was based upon historical data analysis, event description and review of a pictures.The provided pictures show the following situation: the femoral component (nx036z) on the right-side shows bone cement adhesive on nearly the whole intended area.The tibial component (nx057z) on the right-side shows nearly no bone cement residue.The tibial- as well as the femoral component (nx058z and nx016z) on the left side show nearly no bone cement residue.The device quality and manufacturing history records have been checked for the available lot number and were found to be according to the manufacturer's specifications, valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against the affected batch number.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.

• Brand Name: AS VEGA SYSTEM® PS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 22903556
• Report Number: 3005673311-2025-00107
• Device Sequence Number: 7911354
• Product Code: JWH
• UDI-Device Identifier: 04046963810511
• UDI-Public: (01)04046963810511(11)160830(17)260731(10)52268087
• 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: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2026
• Report Date (Section F): 08/27/2025

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: NN264Z
• Device Catalogue Number: NN264Z
• Device Lot Number: 52327531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2025
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2025
• 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: 08/27/2025
• Supplement Report FDA Received Date: 09/30/2025; 12/09/2025; 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 Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/27/2025