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
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, it was reported that there was postoperative loosening.A revision surgery had been planned.Additional information was not provided.The adverse event is filed under aesculap ag reference no.(b)(4).
Event or Problem Description
An outside law firm reported that a patient experienced ongoing issues following a right knee prosthesis.According to the operative report, a patient with a history of bilateral knee degenerative joint disease and prior total knee arthroplasties presented with ongoing musculoskeletal complaints.The patient underwent a right total knee arthroplasty (tka) on (b)(6) 2016 without intraoperative complications.Subsequently, after a motor vehicle accident in (b)(6) 2022, the patient reported neck, back, hip, and left knee pain.Imaging at that time demonstrated a left total knee prosthesis in place with normal alignment and no evidence of loosening or instability.The patient continued to report left lower extremity pain with radicular symptoms.At a later follow-up on (b)(6) 2025, the patient presented with right knee pain and laxity.Imaging findings suggested loosening of the right knee prosthesis with suspected component failure, and additional imaging was planned for further evaluation.A clinic note dated (b)(6) 2026 documented persistent right knee pain that had not improved with injections or physical therapy.The event 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: 24571063
• Report Number: 3005673311-2026-00008
• Device Sequence Number: 13151930
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)150505(17)250430(10)52138448
• 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: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026
• Report Date (Section F): 02/25/2026

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 Expiration Date: 04/30/2025
• Device Model Number: NX060Z
• Device Catalogue Number: NX060Z
• Device Lot Number: 52138448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/19/2026
• Device Age: 130 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2026
• 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: 03/11/2026
• Supplement Report FDA Received Date: 04/27/2026; 06/29/2026
• 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
• Patient Weight: 82 KG
• Date Report Sent to FDA: 02/25/2026