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

Model Number	NX063Z
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 complications associated with a left total knee replacement (tkr).According to clinical documentation, the patient underwent a revision left total knee arthroplasty on (b)(6) 2026 for a failed left total knee replacement with chronic pain.Operative findings documented loosening of the femoral component, which was easily removed from the cement mantle with no bonding on the posterior aspect of the femoral prosthesis.The tibial component was also removed without significant difficulty or bone loss.The procedure involved removal of the failed femoral and tibial components and implantation of another manufacturers system.No intraoperative complications were reported.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: 25664687
• Report Number: 3005673311-2026-00132
• Device Sequence Number: 21444425
• Product Code: JWH
• UDI-Device Identifier: 04046963810573
• UDI-Public: (01)04046963810573(17)311130(10)52726469
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026
• Report Date (Section F): 06/30/2026

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: NX063Z
• Device Catalogue Number: NX063Z
• Device Lot Number: 52726469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2026
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 07/21/2026
• 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: 06/30/2026