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 postoperative loosening.According to the operative report, the patient, with a history of right knee degenerative joint disease, underwent a right total knee replacement on (b)(6) 2022.The procedure was completed without intraoperative complications.A subsequent clinic note dated (b)(6) 2025 indicates that the patient continued to experience symptoms and would likely require further knee replacement intervention.This report is filed under ais reference (b)(4).
Event or Problem Description
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: 24971207
• Report Number: 24971207
• Device Sequence Number: 10455635
• Product Code: JWH
• UDI-Device Identifier: 04046963655808
• UDI-Public: (01)04046963655808(11)211122(17)311121(10)52728599
• 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: 2022
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026
• Report Date (Section F): 08/12/2026

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: 52728599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/19/2026; 08/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 205 LB
• Patient Race: White
• Date Report Sent to FDA: 04/23/2026