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 outside law firm reported that a patient experienced ongoing issues following a left knee prosthesis.According to the operative report, the patient underwent a left total knee arthroplasty on (b)(6), 2021 for degenerative joint disease.The procedure was completed without intraoperative complications.Postoperatively, the patient initially reported improvement, with follow-up on (b)(6) 2021 noting that the patient was doing well with no pain or complaints.However, by february 21, 2022, the patient reported a fall with subsequent left knee pain, decreased range of motion, and ligamentous instability.Imaging and clinical findings at that time noted degenerative changes and laxity.The patient continued to report persistent knee symptoms despite conservative management, including injections.By june 24, 2022, the patient reported ongoing knee pain, though imaging did not demonstrate loosening at that time.At follow-up on (b)(6), 2026, imaging demonstrated a left total knee prosthesis in place with findings of mechanical loosening of the femoral component, associated lucency, and instability.Clinical examination confirmed ligamentous laxity, effusion, and pain.Diagnoses included mechanical loosening and instability of the left knee prosthetic joint.No infection or revision surgery was documented in the available records.This report is filed under ais reference (b)(4).
Event or Problem Description
An outside law firm reported that a patient experienced ongoing issues following a left knee prosthesis.According to the operative report, the patient underwent a left total knee arthroplasty on (b)(6), 2021 for degenerative joint disease.The procedure was completed without intraoperative complications.Postoperatively, the patient initially reported improvement, with follow-up on (b)(6), 2021 noting that the patient was doing well with no pain or complaints.However, by (b)(6), 2022, the patient reported a fall with subsequent left knee pain, decreased range of motion, and ligamentous instability.Imaging and clinical findings at that time noted degenerative changes and laxity.The patient continued to report persistent knee symptoms despite conservative management, including injections.By (b)(6), 2022, the patient reported ongoing knee pain, though imaging did not demonstrate loosening at that time.At follow-up on (b)(6), 2026, imaging demonstrated a left total knee prosthesis in place with findings of mechanical loosening of the femoral component, associated lucency, and instability.Clinical examination confirmed ligamentous laxity, effusion, and pain.Diagnoses included mechanical loosening and instability of the left knee prosthetic joint.No infection or revision surgery was documented in the available records.This report is filed under ais reference xc 100041738 cc 400755910.

• 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: 24999157
• Report Number: 3005673311-2026-00081
• Device Sequence Number: 9813780
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(17)301031(10)52640908
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026
• Report Date (Section F): 04/27/2026

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: 52640908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 07/14/2026
• 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: 04/27/2026