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

Model Number	NX060Z
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
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.Additional information was not provided.
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.
Event or Problem Description
The patient underwent revision left total knee arthroplasty on 22-dec-2025 due to a loose total knee arthroplasty with gross instability.During revision surgery, the surgeon documented gross loosening of both the femoral and tibial components of the implanted aesculap vega knee system.The surgeon noted that the cement had completely debonded from both the femoral and tibial implants.The debonding was so pronounced that the implant imprints remained visible in the intact cement mantle following implant removal.The surgeon reported that the femoral component was grossly loose and could be removed with a periosteal elevator.The tibial component was also grossly loose and was easily removed with a periosteal elevator.The patellar button was additionally found to be loose and was removed.The event required revision total knee arthroplasty involving femoral and tibial component revision and patellar button removal.No intraoperative complications were reported.Patient was transferred to pacu in stable condition following revision surgery.The adverse event is filed under ais reference xc 100041741 cc 400749557.

• Brand Name: AS
• 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: 24567959
• Report Number: 3005673311-2026-00012
• Device Sequence Number: 13138513
• 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): 04/06/2026

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: NX060Z
• Device Catalogue Number: NX060Z
• Device Lot Number: 52679492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 56 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/06/2026; 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
• Patient Weight: 160 LB
• Date Report Sent to FDA: 02/25/2026