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

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
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
An outside law firm reported that a patient experienced post-operative loosening following a left knee arthroplasty procedure that required subsequent medical intervention.According to the operative report dated (b)(6) 2018, the patient underwent a primary left total knee arthroplasty for degenerative joint disease (djd).The procedure was performed using cemented components, and the operative report indicates that the implants were placed with appropriate alignment and stability.The patient tolerated the procedure well and was transferred to recovery in stable condition.No intraoperative complications were reported.According to a subsequent operative report dated july 21, 2025, the patient underwent a revision left total knee arthroplasty due to failed prior knee prosthesis with loosening of components.Intraoperatively, the tibial and femoral components were noted to be loose and were removed without difficulty.Revision components were implanted using bone cement, and trialing demonstrated stability through range of motion without varus or valgus laxity.The operative report indicates that the patient was taken to recovery in stable condition and no intraoperative complications were reported.However, a small medial tibial crack was identified after cement curing, which was noted to be stable without apparent movement and managed with postoperative immobilization and restricted weight-bearing.

• Brand Name: AS VEGA SYSTEM® PS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 24649231
• Report Number: 3005673311-2026-00034
• Device Sequence Number: 16004393
• Product Code: JWH
• UDI-Device Identifier: 04046963811242
• UDI-Public: (01)04046963811242(11)180417(17)230331(10)52425736
• 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: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2026
• Report Date (Section F): 03/20/2026

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: 03/31/2023
• Device Model Number: NX230
• Device Catalogue Number: NX230
• Device Lot Number: 52425736
• 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: 87 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• 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: 03/20/2026