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 and instability following a right total knee arthroplasty.According to the available medical records, the patient underwent a right total knee arthroplasty on (b)(6) 2021.The patient subsequently developed loosening of the right total knee arthroplasty with gross instability.On (b)(6) 2024, the patient underwent revision right total knee arthroplasty involving the femoral and tibial components.The preoperative and postoperative diagnoses were documented as right knee loose total knee arthroplasty with gross instability.During the revision procedure, the femoral component was visualized and reportedly came right off when grasped.The tibial prosthesis was loosened and removed easily with minimal bone loss.The patellar button was also assessed intraoperatively and was documented to be loose.The femur and tibia were prepared for revision components.Following trialing, the knee demonstrated full range of motion with excellent stability to varus and valgus stress.The revision components were cemented into place using a third-generation cement technique.The patient was awakened from surgery and taken to the pacu in stable condition.At postoperative follow-up on (b)(6) 2025, the patient was documented as progressing as expected.Pain levels were appropriate, the incision was clean, dry, and intact, there was no evidence of dvt or swelling, neurovascular status was normal, and range of motion was normal for the postoperative timeframe.This report is filed under ais reference (b)(6); (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: 50260853
• Report Number: 50260853
• Device Sequence Number: 10125144
• 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: 2024
• 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: 07/24/2026
• Device Age: 53 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