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	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced postoperative loosening following a left total knee arthroplasty.According to the available medical records, the patient underwent a left total knee arthroplasty on (b)(6) 2021.On (b)(6) 2024, the patient underwent revision of the left patellar component for aseptic loosening.The operative report documented that the femoral and tibial components were inspected and appeared to have no loosening.The patellar button was evaluated, and when an osteotome was placed at the medial side of the button, the button reportedly popped out.The remaining cement was removed from the patella and the patella was resurfaced to allow for improved tracking.No intraoperative complications were reported, and the patient was taken to recovery in stable condition.Subsequent records documented further concerns involving the left total knee prosthesis.At a (b)(6) 2025 postoperative evaluation, radiographs demonstrated a posterior-stabilized total knee replacement with the patella resurfaced.The femoral component appeared loose, with severe periprosthetic osteolysis about the femur.The patient was assessed with mechanical loosening and periprosthetic osteolysis of the internal left knee prosthetic joint.At a (b)(6) 2026 preoperative evaluation, radiographs documented that the femoral and tibial components appeared loose.Revision of the left total knee arthroplasty involving the femoral and entire tibial components was recommended.The records provided do not include the subsequent revision operative report; therefore, explantation of the femoral and tibial components cannot be confirmed from the available documentation.This report is filed under ais reference (b)(4).

• 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: 50260355
• Report Number: 50260355
• Device Sequence Number: 18673386
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)200701(17)300630(10)52621015
• 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: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026
• Report Date (Section F): 09/15/2026

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: 52621015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2026
• Device Age: 71 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/15/2026
• 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: Female
• Date Report Sent to FDA: 08/14/2026