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

Model Number	NX055Z
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
According to the complainant the knee implant was defective and failed prematurely because the ceramic coated surface fails to properly adhere to the cement.Additional information has been requested but not yet provided.
Event or Problem Description
An outside law firm reported that a patient experienced issues following a left knee prosthesis that required subsequent medical intervention.According to the operative report dated on (b)(6) 2021, the patient underwent a primary left total knee arthroplasty for tricompartmental degenerative joint disease (djd) with marked tibial torsion.The procedure was performed using aesculap components, which were cemented in place using palacos bone cement.The operative report indicates that the components were implanted with appropriate alignment and stability, and the patient was taken to recovery in good condition.No intraoperative complications were reported.According to a subsequent operative report dated on (b)(6) 2023, the patient underwent left knee manipulation under anesthesia due to postoperative adhesive capsulitis.The procedure involved manipulation of the knee from full extension to approximately 125 degrees of flexion.No audible or palpable abnormalities were noted, and no structural changes to the knee were identified during the procedure.The patient tolerated the procedure well and was taken to recovery in good condition.No intraoperative complications were reported.
Event or Problem Description
An outside law firm reported that a patient experienced issues following a left knee prosthesis that required subsequent medical intervention.According to the operative report dated on (b)(6) 2021, the patient underwent a primary left total knee arthroplasty for tricompartmental degenerative joint disease (djd) with marked tibial torsion.The procedure was performed using aesculap components, which were cemented in place using palacos bone cement.The operative report indicates that the components were implanted with appropriate alignment and stability, and the patient was taken to recovery in good condition.No intraoperative complications were reported.According to a subsequent operative report dated on (b)(6) 2023, the patient underwent left knee manipulation under anesthesia due to postoperative adhesive capsulitis.The procedure involved manipulation of the knee from full extension to approximately 125 degrees of flexion.No audible or palpable abnormalities were noted, and no structural changes to the knee were identified during the procedure.The patient tolerated the procedure well and was taken to recovery in good condition.No intraoperative complications were reported.Subsequently, the left total knee arthroplasty failed due to loosening of the implanted components.On (b)(6) 2025, the patient underwent revision left total knee arthroplasty for a failed loose left total knee.During surgery, the surgeon documented that the femoral component was loose and could be removed easily.The cement remained attached to the bone while the femoral component demonstrated very limited cement attachment.The tibial component was also easily removed.Significant synovitis and joint fluid were present.No significant bone loss was noted.Revision of both components was performed using implants from another manufacturer.The patella was retained.No intraoperative complications were reported.The patient was taken to recovery in good condition.This report is filed under ais reference (b)(4).

• 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: 23535570
• Report Number: 3005673311-2025-00135
• Device Sequence Number: 21374204
• 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: 2021
• Device Explanted Year: 2025
• 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): 03/19/2026

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: NX055Z
• Device Catalogue Number: NX055Z
• Device Lot Number: 52631120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 74 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• 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: 11/12/2025
• Supplement Report FDA Received Date: 11/25/2025; 03/19/2026; 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: Female
• Date Report Sent to FDA: 11/12/2025