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

Model Number	NX060Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced loosening of the right knee prosthesis.The patient underwent right total knee arthroplasty on (b)(6) 2018 for right knee degenerative joint disease.The operative report documents implantation of total knee arthroplasty components.The procedure was completed without reported intraoperative complications, and the patient was transferred to the pacu in stable condition.Postoperative follow-up on (b)(6) 2018 documented that the right knee was straight and anatomically aligned and that the patient had no complaints or problems.On (b)(6) 2018, the patient reported feeling something "pop" anteriorly around the knee and had anterior tenderness.Radiographs were reported as completely normal.The patient received an intramuscular depo-medrol injection for pain and swelling.At follow-up on (b)(6) 2018, the patient was reported to be significantly improved, although some lateral collateral ligament symptoms remained.On (b)(6) 2018, the patient was reported to be doing fairly well, with keloid formation/scarring and continued patellofemoral pain.On (b)(6) 2026, approximately eight years after the index arthroplasty, the patient presented for evaluation of right knee pain.Radiographic evaluation documented a posterior-stabilized total knee replacement in place and indicated that the femoral component appeared loose.The clinical assessment documented likely failure due to debonding with shifting of the implant.The right knee was aspirated, yielding approximately 10 cc of serosanguinous fluid.The patient also received an intramuscular ketorolac injection for symptoms.Revision right total knee arthroplasty was reportedly scheduled for (b)(6) 2026.This report is filed under ais reference (b)(4).
Event or Problem Description
An outside law firm reported that a patient experienced loosening of the right knee prosthesis.The patient underwent right total knee arthroplasty on (b)(6), 2018 for right knee degenerative joint disease.The operative report documents implantation of total knee arthroplasty components.The procedure was completed without reported intraoperative complications, and the patient was transferred to the pacu in stable condition.Postoperative follow-up on (b)(6), 2018 documented that the right knee was straight and anatomically aligned and that the patient had no complaints or problems.On (b)(6), 2018, the patient reported feeling something "pop" anteriorly around the knee and had anterior tenderness.Radiographs were reported as completely normal.The patient received an intramuscular depo-medrol injection for pain and swelling.At follow-up on (b)(6), 2018, the patient was reported to be significantly improved, although some lateral collateral ligament symptoms remained.On (b)(6), 2018, the patient was reported to be doing fairly well, with keloid formation/scarring and continued patellofemoral pain.On (b)(6), 2026, approximately eight years after the index arthroplasty, the patient presented for evaluation of right knee pain.Radiographic evaluation documented a posterior-stabilized total knee replacement in place and indicated that the femoral component appeared loose.The clinical assessment documented likely failure due to debonding with shifting of the implant.The right knee was aspirated, yielding approximately 10 cc of serosanguinous fluid.The patient also received an intramuscular ketorolac injection for symptoms.The patient underwent revision right total knee arthroplasty on (b)(6), 2026 for a loose right total knee arthroplasty with gross instability.Intraoperative findings documented gross loosening of the femoral and tibial components.The surgeon reported cement debonding from the tibial component and noted the tibia had no bone cement attached, describing the finding as a classic aesculap failure.The femoral component was loose and the tibial component was removed with minimal bone loss.Revision arthroplasty of the femoral and tibial components was performed using zimmer persona revision components with cones, stems, augments, and tibial insert.No intraoperative complications were reported and the patient was transferred to pacu in stable condition.This report is filed under ais reference xc (b)(6); cc (b)(6).

• Brand Name: AS
• 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: 50275306
• Report Number: 50275306
• Device Sequence Number: 13191310
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)170711(17)270630(10)52348552
• 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: 2018
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026
• Report Date (Section F): 09/25/2026

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: 52348552
• 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: 109 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: 08/17/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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: 08/17/2026