MAUDE Adverse Event Report: AESCULAP AG; KNEE ENDOPROSTHETICS

Model Number	NX031Z
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
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
An adverse event was reported involving an unknown aesculap ag knee implant system.Specifically, an outside law firm reported that a patient experienced postoperative loosening.A revision surgery had been planned.Additional information was not provided.The adverse event is filed under aesculap inc.Reference no.(b)(4).
Event or Problem Description
An outside law firm reported that a patient experienced ongoing issues involving a right knee prosthesis.According to operative records, the patient underwent a right total knee arthroplasty on (b)(6) 2022, for avascular necrosis (avn) of the lateral tibial plateau.The procedure utilized aesculap vega components which were cemented using palacos cement.The operative report indicated the procedure was completed without reported intraoperative complications, and the knee demonstrated full extension and flexion with central patellar tracking at the conclusion of surgery.At a follow-up visit on (b)(6)2023, the patient reported continued pain and discomfort, as well as weakness involving the quadriceps.Radiographs of the knee were obtained, and quadriceps weakness was noted on examination.At a subsequent follow-up on (b)(6)2024, the patient reported pain and discomfort involving the right knee.Physical examination documented instability of the knee joint, and the patient reported falls and functional difficulties.Revision surgery was discussed.During a follow-up visit on (b)(6)2025, the patient continued to report instability and recurrent falls.Examination documented medial and lateral laxity, with worsening symptoms.Revision of the right knee arthroplasty was recommended.On january 12, 2026, the patient reported worsening right knee symptoms, including increased pain and instability.During a preoperative evaluation on (b)(6)2026, the patient continued to report pain and instability and was preparing for revision surgery.On (b)(6)2026, the patient underwent revision right total knee arthroplasty.According to the operative report, the preoperative diagnosis was failed right total knee replacement.Intraoperative findings documented loosening of the femoral component, which had separated completely from the cement interface and was removed without difficulty.The tibial component remained stable.The original components were revised using another manufacturers revision knee system.No intraoperative complications were reported.This report is filed under ais reference(b)(4).

• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 24583872
• Report Number: 3005673311-2026-00004
• Device Sequence Number: 10326281
• 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: 2022
• Device Explanted Year: 2026
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026
• Report Date (Section F): 06/09/2026

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: NX031Z
• Device Catalogue Number: NX031Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2026
• 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: 03/12/2026
• Supplement Report FDA Received Date: 06/01/2026; 06/09/2026
• 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: 02/26/2026